Document and Entity Information - shares	9 Months Ended
Document and Entity Information - shares	Sep. 30, 2016	Oct. 31, 2016
Document And Entity Information
Entity Registrant Name	TherapeuticsMD, Inc.
Entity Central Index Key	0000025743
Document Type	10-Q
Trading Symbol	TXMD
Document Period End Date	Sep. 30, 2016
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Is Entity a Well-known Seasoned Issuer	No
Is Entity a Voluntary Filer	No
Is Entity's Reporting Status Current	Yes
Entity Filer Category	Large Accelerated Filer
Entity Common Stock, Shares Outstanding		196,580,212
Document Fiscal Period Focus	Q3
Document Fiscal Year Focus	2016

CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($)	Sep. 30, 2016	Dec. 31, 2015
Current Assets:
Cash	$ 147,534,065	$ 64,706,355
Accounts receivable, net of allowance for doubtful accounts of $113,034 and $81,910, respectively	5,033,298	3,049,715
Inventory	843,398	690,153
Other current assets	2,693,475	2,233,897
Total current assets	156,104,236	70,680,120
Fixed assets, net	460,546	198,592
Other Assets:
Intangible assets, net	2,118,378	1,615,251
Prepaid expense		1,109,883
Security deposit	139,036	125,000
Total other assets	2,257,414	2,850,134
Total assets	158,822,196	73,728,846
Current Liabilities:
Accounts payable	4,224,419	3,126,174
Other current liabilities	8,243,421	7,539,526
Total current liabilities	12,467,840	10,665,700
Total liabilities	12,467,840	10,665,700
Commitments and Contingencies - See Note 15
Stockholders' Equity:
Preferred stock - par value $0.001; 10,000,000 shares authorized; no shares issued and outstanding
Common stock - par value $0.001; 350,000,000 shares authorized; 196,580,212 and 177,928,041 issued and outstanding, respectively	196,580	177,928
Additional paid in capital	433,023,801	282,712,078
Accumulated deficit	(286,866,025)	(219,826,860)
Total stockholders' equity	146,354,356	63,063,146
Total liabilities and stockholders' equity	$ 158,822,196	$ 73,728,846

CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - USD ($)	Sep. 30, 2016	Dec. 31, 2015
Statement of Financial Position [Abstract]
Allowance for doubtful accounts	$ 113,034	$ 81,910
Preferred stock, par value (in dollars per share)	$ 0.001	$ 0.001
Preferred stock, shares authorized	10,000,000	10,000,000
Preferred stock, shares issued	0	0
Preferred stock, shares outstanding	0	0
Common stock, par value (in dollars per share)	$ 0.001	$ 0.001
Common stock, shares authorized	350,000,000	350,000,000
Common stock, shares issued	196,580,212	177,928,041
Common stock, shares outstanding	196,580,212	177,928,041

CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2016	Sep. 30, 2015	Sep. 30, 2016	Sep. 30, 2015
Income Statement [Abstract]
Revenues, net	$ 5,535,685	$ 5,190,175	$ 14,869,023	$ 14,513,158
Cost of goods sold	1,237,446	1,193,965	3,475,997	3,270,695
Gross profit	4,298,239	3,996,210	11,393,026	11,242,463
Operating expenses:
Sales, general, and administration	14,721,710	7,060,944	35,019,268	20,089,998
Research and development	14,664,123	16,421,753	43,602,333	58,789,302
Depreciation and amortization	40,460	16,548	84,319	44,400
Total operating expense	29,426,293	23,499,245	78,705,920	78,923,700
Operating loss	(25,128,054)	(19,503,035)	(67,312,894)	(67,681,237)
Other income:
Miscellaneous income	109,942	27,630	265,879	71,728
Accreted interest	2,451	2,760	7,850	15,162
Total other income	112,393	30,390	273,729	86,890
Loss before taxes	(25,015,661)	(19,472,645)	(67,039,165)	(67,594,347)
Net loss	$ (25,015,661)	$ (19,472,645)	$ (67,039,165)	$ (67,594,347)
Net loss per share, basic and diluted (in dollars per share)	$ (0.13)	$ (0.11)	$ (0.34)	$ (0.39)
Weighted average number of common shares outstanding, basic and diluted (in shares)	196,502,327	177,206,168	195,912,173	171,589,595

CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($)	9 Months Ended
	Sep. 30, 2016	Sep. 30, 2015
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$ (67,039,165)	$ (67,594,347)
Adjustments to reconcile net loss to net cash flows used in operating activities:
Depreciation of fixed assets	45,759	22,104
Amortization of intangible assets	38,560	22,296
Provision for doubtful accounts	2,261,568	37,163
Share-based compensation	13,385,215	4,740,906
Changes in operating assets and liabilities:
Accounts receivable	(4,245,151)	(1,549,532)
Inventory	(153,245)	312,054
Other current assets	379,930	(621,923)
Other assets		(15,162)
Accounts payable	1,098,245	(1,025,504)
Deferred revenue		(522,613)
Other current liabilities	703,895	2,546,138
Other long-term liabilities		1,213,874
Net cash used in operating activities	(53,524,389)	(62,434,546)
CASH FLOWS FROM INVESTING ACTIVITIES
Patent costs	(541,686)	(117,992)
Purchase of fixed assets	(307,714)	(15,559)
Payment of security deposit	(14,036)
Net cash used in investing activities	(863,436)	(133,551)
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from sale of common stock, net of costs	134,863,475	91,374,649
Proceeds from exercise of warrants	1,373,000	366,000
Proceeds from exercise of options	979,060	589,829
Net cash provided by financing activities	137,215,535	92,330,478
Increase in cash	82,827,710	29,762,381
Cash, beginning of period	64,706,355	51,361,607
Cash, end of period	$ 147,534,065	$ 81,123,988

THE COMPANY

9 Months Ended

Sep. 30, 2016

Organization, Consolidation and Presentation of Financial Statements [Abstract]

THE COMPANY

NOTE 1 – THE COMPANY

TherapeuticsMD, Inc., a Nevada corporation, or TherapeuticsMD or the Company, has three wholly owned subsidiaries, vitaMedMD, LLC, a Delaware limited liability company, or VitaMed; BocaGreenMD, Inc., a Nevada corporation, or BocaGreen; and VitaCare Prescription Services, Inc., a Florida corporation, or VitaCare. Unless the context otherwise requires, TherapeuticsMD, VitaMed, BocaGreen, and VitaCare collectively are sometimes referred to as “our company,” “we,” “our,” or “us.”

Nature of Business

We are a women’s health care product company focused on developing and commercializing products targeted exclusively for women. As of the date of these unaudited consolidated financial statements, we are focused on conducting the clinical trials and pursuing the regulatory approvals and pre-commercialization activities necessary for commercialization of our advanced hormone therapy pharmaceutical products. The drug candidates used in our clinical trials are designed to alleviate the symptoms of and reduce the health risks resulting from menopause-related hormone deficiencies, including hot flashes, osteoporosis, and vaginal discomfort. We are developing these hormone therapy drug candidates, which contain estradiol and progesterone alone or in combination, with the aim of demonstrating equivalent clinical efficacy at lower doses, thereby enabling an enhanced side effect profile compared with competing products. Our drug candidates are developed using our SYMBODA technology to enable delivery of bio-identical hormones through a variety of dosage forms and administration routes. In addition, we manufacture and distribute branded and generic prescription prenatal vitamins, as well as over-the-counter, or OTC, vitamins.

BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS

9 Months Ended

Sep. 30, 2016

Organization, Consolidation and Presentation of Financial Statements [Abstract]

BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS

NOTE 2 – BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS

Interim Financial Statements

The accompanying unaudited interim consolidated financial statements of TherapeuticsMD, Inc., which include our wholly owned subsidiaries, should be read in conjunction with the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2015, as filed with the Securities and Exchange Commission, or the SEC, from which we derived the accompanying consolidated balance sheet as of December 31, 2015. The accompanying unaudited interim consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP, for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, since they are interim statements, the accompanying unaudited interim consolidated financial statements do not include all of the information and notes required by GAAP for complete financial statements. The accompanying unaudited interim consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, that are, in the opinion of our management, necessary to a fair statement of the results for the interim periods presented. Interim results are not necessarily indicative of results for a full year or any other interim period in the future.

Recently Issued Accounting Pronouncements

In August 2016, the Financial Accounting Standards Board, or FASB, issued ASU 2016-15, Statement of Cash Flows (Topic 230). ASU 2016-15 is intended to reduce the diversity in practice regarding how certain transactions are classified within the statement of cash flows. ASU 2016-15 is effective for public business entities for annual periods beginning after December 15, 2017, including interim periods within those fiscal years. Early adoption is permitted with retrospective application. We are currently evaluating the impact of this guidance on our consolidated financial statements and disclosures.

In March 2016, the FASB issued ASU 2016-09, Compensation – Stock Compensation: Improvements to Employee Share-Based Payment Accounting. This guidance simplifies several aspects of the accounting for employee share-based payment transactions for both public and nonpublic entities, including the accounting for income taxes, forfeitures, and statutory tax withholding requirements, as well as classification in the statement of cash flows. The guidance is effective for public business entities for fiscal years beginning after December 15, 2016, and interim periods within those fiscal years. Early adoption is permitted in any annual or interim period for which financial statements have not been issued or made available for issuance, but all of the guidance must be adopted in the same period. If an entity early adopts the guidance in an interim period, any adjustments must be reflected as of the beginning of the fiscal year that includes that interim period. We are currently evaluating the impact of this guidance on our consolidated financial statements and disclosures.

In February 2016, the FASB issued ASU 2016-02, Leases. This guidance requires lessees to record most leases on their balance sheets but recognize expenses on their income statements in a manner similar to current accounting. The guidance also eliminates current real estate-specific provisions for all entities. For lessors, the guidance modifies the classification criteria and the accounting for sales-type and direct financing leases. The standard is effective for public business entities for annual periods beginning after December 15, 2018, and interim periods within those years. Early adoption is permitted for all entities. We are currently evaluating the impact of this guidance on our consolidated financial statements and disclosures.

In July 2015, the FASB issued ASU 2015-11, Inventory (Topic 330), simplifying the Measurement of Inventory. This guidance requires entities to measure inventory at the lower of cost or net realizable value rather than at the lower of cost or market (LOCOM). The guidance applies only to inventories for which cost is determined by methods other than last-in first-out (LIFO) or the retail inventory method (RIM). Entities that use LIFO or RIM will continue to use existing impairment models. The new guidance does not change the calculation of net realizable value that entities are required to calculate when applying existing LOCOM guidance. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal and transportation. Under the new guidance, however, entities will no longer need to calculate other measures of “market.” The guidance is effective for public business entities for fiscal years beginning after December 15, 2016, and interim periods within those fiscal years. Early adoption is permitted. We are currently evaluating the impact of this guidance, if any, on our consolidated financial statements and disclosures.

In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements-Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. ASU 2014-15 requires management to evaluate whether there are conditions and events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the financial statements are issued (or available to be issued when applicable) and, if so, disclose that fact. ASU 2014-15 is effective for annual periods ending after December 15, 2016 and interim periods within annual periods beginning after December 15, 2016. Early adoption is permitted for annual or interim reporting periods for which the financial statements have not previously been issued. We do not expect the adoption of ASU 2014-15 to have a material effect on our consolidated financial statements and disclosures.

In May 2014, the FASB and the International Accounting Standards Board (IASB) issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606). The standard’s core principle is that a company will recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. In doing so, companies will need to use more judgment and make more estimates than under previous guidance. These may include identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each separate performance obligations. In July 2015, the FASB approved the proposal to defer the effective date of ASU 2014-09 standard by one year. Early adoption is permitted after December 15, 2016, and the standard is effective for public entities for annual reporting periods beginning after December 15, 2017 and interim periods therein. In 2016, the FASB issued final amendments to clarify the implementation guidance for principal versus agent considerations (ASU 2016-08) as well as accounting for licenses of intellectual property and identifying performance obligations (ASU 2016-10) and narrow-scope improvements and practical expedients (ASU 2016-12) in its new revenue standard. We are currently evaluating the impact of this guidance on our consolidated financial statements and disclosures.

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

9 Months Ended

Sep. 30, 2016

Accounting Policies [Abstract]

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Fair Value of Financial Instruments

Our financial instruments consist primarily of accounts receivable, accounts payable and accrued expenses. The carrying amount of accounts receivable, accounts payable and accrued expenses approximates their fair value because of the short-term maturity of such instruments, which are considered Level 1 assets under the fair value hierarchy.

We categorize our assets and liabilities that are valued at fair value on a recurring basis into a three-level fair value hierarchy as defined by Accounting Standards Codification, or ASC, 820, Fair Value Measurements. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets and liabilities (Level 1) and lowest priority to unobservable inputs (Level 3). Assets and liabilities recorded in the consolidated balance sheet at fair value are categorized based on a hierarchy of inputs, as follows:

Level 1

unadjusted quoted prices in active markets for identical assets or liabilities;

Level 2

quoted prices for similar assets or liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument; and

Level 3

unobservable inputs for the asset or liability.

At September 30, 2016 and December 31, 2015, we had no assets or liabilities that were valued at fair value on a recurring basis. The fair value of indefinite-lived assets or long-lived assets is measured on a non-recurring basis using significant unobservable inputs (Level 3) in connection with our impairment test. There was no impairment of intangible assets or long-lived assets during the three and nine months ended September 30, 2016 and 2015.

Revenue Recognition

We recognize revenue on arrangements in accordance with ASC 605, Revenue Recognition. We recognize revenue only when the price is fixed or determinable, persuasive evidence of an arrangement exists, the service is performed, and collectability is reasonably assured.

Our OTC and prescription prenatal vitamin products are generally variations of the same product with slight modifications in formulation and marketing. The primary difference between our OTC and prescription prenatal vitamin products is the source of payment. Purchasers of our OTC prenatal vitamin products pay for the product directly while purchasers of our prescription prenatal vitamin products pay for the product primarily via third-party payers. Both OTC and prescription prenatal vitamin products share the same marketing support team utilizing similar marketing techniques. The revenue that is generated by us from major customers is all generated from sales of our prescription prenatal vitamin products which is disclosed in Note 14. There are no major customers for our OTC prenatal vitamin or other products.

Over-the-Counter Products

We generate OTC revenue from product sales primarily to retail consumers. We recognize revenue from product sales upon shipment, when the rights of ownership and risk of loss have passed to the consumer. We include outbound shipping and handling fees in revenues, net, and bill them upon shipment. We include shipping expenses in cost of goods sold. A majority of our OTC customers pay for our products with credit cards, and we usually receive the cash settlement in two to three banking days. Credit card sales minimize accounts receivable balances relative to OTC sales. We provide an unconditional 30-day money-back return policy under which we accept product returns from our retail and eCommerce OTC customers. We recognize revenue from OTC sales, net of estimated returns, sales discounts, and eCommerce fees.

Prescription Products

We sell our name brand and generic prescription products primarily through drug wholesalers and retail pharmacies. We recognize revenue from prescription product sales, net of sales discounts, chargebacks, and customer rebates. We accept returns of unsalable prescription products from customers within a return period of six months prior to and up to 12 months following product expiration. Our prescription products currently have a shelf life of 24 months from the date of manufacture. We estimate returns based on historical return rates and recorded actual product returns against this reserve as received. We offer various rebate programs in an effort to maintain a competitive position in the marketplace and to promote sales and customer loyalty. The consumer rebate program is designed to enable the end user to submit a coupon to us. If the coupon qualifies, we send a rebate check to the end user. We estimate the allowance for consumer rebates that we have offered based on our experience and industry averages, which is reviewed, and adjusted if necessary, on a quarterly basis.

Share-Based Compensation

We measure the compensation costs of share-based compensation arrangements based on the grant-date fair value and recognize the costs in the financial statements over the period during which employees are required to provide services. Share-based compensation arrangements include options, restricted stock, restricted stock units, performance-based awards, share appreciation rights, and employee share purchase plans. As such, compensation cost is measured on the date of grant at fair value. We amortize such compensation amounts, if any, over the requisite service periods of the award. We use the Black-Scholes-Merton option pricing model, or the Black-Scholes Model, an acceptable model in accordance with ASC 718, Compensation—Stock Compensation, to value options. Calculating share-based compensation expense requires the input of highly subjective judgment and assumptions, including forfeiture rates, estimates of expected life of the share-based award, stock price volatility and risk-free interest rates. The assumptions used in calculating the fair value of share-based awards represent our best estimates, but these estimates involve inherent uncertainties and the application of management judgment. As a result, if factors change and we use different assumptions, our share-based compensation expense could be materially different in the future.

Equity instruments issued to non-employees are recorded on the basis of the fair value of the instruments, as required by ASC 505, Equity - Based Payments to Non-Employees, or ASC 505. ASC 505 defines the measurement date and recognition period for such instruments. In general, the measurement date is when either (a) a performance commitment, as defined, is reached or (b) the earlier of (i) the non-employee performance is complete or (ii) the instruments are vested. The estimated expense is recognized each period based on the current fair value of the award. As a result, the amount of expense related to awards to non-employees can fluctuate significantly during the period from the date of the grant through the final measurement date. The measured value related to the instruments is recognized over a period based on the facts and circumstances of each particular grant as defined in ASC 505.

We generally recognize the compensation expense on a straight-line basis over the employee’s requisite service period. We estimate the forfeiture rate based on our historical experience of forfeitures. If our actual forfeiture rate is materially different from our estimate, share-based compensation expense could be significantly different from what we have recorded in the current period.

Research and Development Expenses

Research and development, or R&D, expenses include internal R&D activities, services of external contract research organizations, or CROs, costs of their clinical research sites, manufacturing, scale-up and validation costs, and other activities. Internal R&D activity expenses include laboratory supplies, salaries, benefits, and non-cash share-based compensation expenses. Advance payments to be expensed in future research and development activities are capitalized, and were $244,335 at September 30, 2016, all of which was included in other current assets on the accompanying consolidated balance sheets. Advance payments to be expensed in future research and development activities were $1,138,073 at December 31, 2015, of which $1,009,175 was included in other current assets and $128,898 was included in long term prepaid expense on the accompanying consolidated balance sheets. CRO activity expenses include preclinical laboratory experiments and clinical trial studies. Other activity expenses include regulatory consulting and legal fees and costs. The activities undertaken by our regulatory consultants that were classified as R&D expenses include assisting, consulting with, and advising our in-house staff with respect to various FDA submission processes, clinical trial processes, and scientific writing matters, including preparing protocols and FDA submissions. Legal activities that were classified as R&D expenses related to designing experiments to generate data for patents and to further the formulation development process for our pipeline technologies. Outside legal counsel also provided professional research and advice regarding R&D, patents and regulatory matters. These consulting and legal expenses were direct costs associated with preparing, reviewing, and undertaking work for our clinical trials and investigative drugs. We charge internal R&D activities and other activity expenses to operations as incurred. We make payments to CROs based on agreed-upon terms, which may include payments in advance of a study starting date. We expense nonrefundable advance payments for goods and services that will be used in future R&D activities when the activity has been performed or when the goods have been received rather than when the payment is made. We review and accrue CRO expenses and clinical trial study expenses based on services performed and rely on estimates of those costs applicable to the completion stage of a study as provided by CROs. Estimated accrued CRO costs are subject to revisions as such studies progress to completion. We charge revisions expense in the period in which the facts that give rise to the revision become known.

Segment Reporting

We are managed and operated as one business, which is focused on creating and commercializing products targeted exclusively for women. Our business operations are managed by a single management team that reports to the President of our Company. We do not operate separate lines of business with respect to any of our products and we do not prepare discrete financial information with respect to separate products. All product sales are derived from sales in the United States. Accordingly, we view our business as one reportable operating segment.

INVENTORY

9 Months Ended

Sep. 30, 2016

Inventory Disclosure [Abstract]

INVENTORY

NOTE 4 – INVENTORY

Inventory consists of the following:

	September 30, 2016		December 31, 2015
Finished product	$	816,400	$	661,167
Raw material		26,998		28,986
TOTAL INVENTORY	$	843,398	$	690,153

FIXED ASSETS, NET

9 Months Ended

Sep. 30, 2016

Property, Plant and Equipment [Abstract]

FIXED ASSETS, NET

NOTE 6 – FIXED ASSETS, NET

Fixed assets consist of the following:

	September 30, 2016			December 31, 2015
Accounting system	$	296,746		$	149,699
Equipment		164,013			132,150
Computer hardware		80,211			—
Furniture and fixtures		80,158			69,454
Leasehold improvements		37,888			—
		659,016			351,303
Accumulated depreciation		(198,470	)		(152,711	)
TOTAL FIXED ASSETS, NET	$	460,546		$	198,592

Depreciation expense for the three months ended September 30, 2016 and 2015 was $26,543 and $7,856, respectively, and $45,759 and $22,104 for the nine months ended September 30, 2016 and 2015, respectively, which was included in operating expenses in the accompanying consolidated financial statements.

INTANGIBLE ASSETS, NET

9 Months Ended

Sep. 30, 2016

Intangible Assets, Net (Excluding Goodwill) [Abstract]

INTANGIBLE ASSETS, NET

NOTE 8 – INTANGIBLE ASSETS, NET

The following table sets forth the gross carrying amount and accumulated amortization of our intangible assets as of September 30, 2016 and December 31, 2015:

	September 30, 2016
	Gross Carrying Amount		Accumulated Amortization			Net Amount		Weighted- Average Remaining Amortization Period (yrs.)
Amortizing intangible assets:
OPERA^®software patent	$	31,951	$	(5,991	)	$	25,960		13
Development costs of corporate website		91,743		(91,743	)		—		n/a
Approved hormone therapy drug candidate patents		959,059		(86,907	)		872,152		16.25
Hormone therapy drug candidate patents (pending)		1,037,829		—			1,037,829		n/a
Non-amortizing intangible assets:
Multiple trademarks		182,437		—			182,437		indefinite
TOTAL	$	2,303,019	$	(184,641	)	$	2,118,378

	December 31, 2015
	Gross Carrying Amount		Accumulated Amortization			Net Amount		Weighted- Average Remaining Amortization Period (yrs.)
Amortizing intangible assets:
OPERA^®software patent	$	31,951	$	(4,493	)	$	27,458		13.75
Development costs of corporate website		91,743		(91,743	)		—		n/a
Approved hormone therapy drug candidate patents		705,752		(49,845	)		655,907		17
Hormone therapy drug candidate patents (pending)		774,165		—			774,165		n/a
Non-amortizing intangible assets:
Multiple trademarks		157,721		—			157,721		indefinite
TOTAL	$	1,761,332	$	(146,081	)	$	1,615,251

We capitalize external costs, consisting primarily of legal costs, related to securing our patents and trademarks. Once a patent is granted, we amortize the approved hormone therapy drug candidate patents using the straight-line method over the estimated useful life of approximately 20 years, which is the life of intellectual property patents. If the patent is not granted, we write-off any capitalized patent costs at that time. Trademarks are perpetual and are not amortized. As of September 30, 2016, the remaining life related to OPERA^® patent was approximately 13 years and the remaining life related to the approved hormone therapy drug candidate patents was approximately 16 years.

In addition to numerous pending patent applications, as of September 30, 2016, we had 17 issued patents, including:

•

13 utility patents that relate to our combination progesterone and estradiol product candidates, which are owned by us and are U.S. jurisdiction patents with expiration dates in 2032. We have pending patent applications with respect to certain of these patents in Argentina, Australia, Brazil, Canada, Europe, Israel, Japan, Mexico, Russia, South Africa, and South Korea;

•

two utility patents that relate to TX-004HR, our applicator-free vaginal estradiol softgel product candidate, which establish an important intellectual property foundation for TX-004HR, which are owned by us and are U.S. jurisdiction patents with expiration dates in 2033 and 2032. We have pending patent applications with respect to certain of these patents in Argentina, Australia, Brazil, Canada, Europe, Israel, Japan, Mexico, Russia, South Africa, and South Korea;

•

one utility patent that relates to a pipeline transdermal patch technology, which is owned by us and is a U.S. jurisdiction patent with an expiration date in 2032. We have pending patent applications with respect to this technology in Australia, Brazil, Canada, Europe, Mexico, Japan, and South Africa; and

•

one utility patent that relates to our OPERA^® information technology platform, which is owned by us and is a U.S. jurisdiction patent with an expiration date in 2029.

Amortization expense was $13,917 and $8,692 for the three months ended September 30, 2016 and 2015, respectively and $38,560 and $22,296 for the nine months ended September 30, 2016 and 2015, respectively. Estimated amortization expense for the next five years is as follows:

Year Ending December 31,		Estimated Amortization
	2016 (3 months)	$	13,917
	2017	$	55,668
	2018	$	55,668
	2019	$	55,668
	2020	$	55,668

OTHER CURRENT LIABILITIES

9 Months Ended

Sep. 30, 2016

Other Liabilities Disclosure [Abstract]

OTHER CURRENT LIABILITIES

NOTE 9 – OTHER CURRENT LIABILITIES

Other current liabilities consist of the following:

	September 30, 2016		December 31, 2015
Accrued clinical trial costs	$	3,778,784	$	3,725,377
Accrued payroll, bonuses and commission costs		1,622,333		2,108,143
Accrued compensated absences		772,958		562,096
Accrued legal and accounting expense		377,172		210,309
Accrued sales and marketing costs		617,961		—
Other accrued expenses		231,037		546,264
Allowance for wholesale distributor fees		100,434		32,659
Accrued royalties		27,495		46,851
Allowance for coupons and returns		564,864		224,300
Accrued rent		150,383		83,527
TOTAL OTHER CURRENT LIABILITIES	$	8,243,421	$	7,539,526

NET LOSS PER SHARE

9 Months Ended

Sep. 30, 2016

Earnings Per Share [Abstract]

NET LOSS PER SHARE

NOTE 10 – NET LOSS PER SHARE

We calculate basic and diluted net loss per share allocable to common stockholders using the weighted-average number of shares of common stock, par value $0.001 per share, or Common Stock outstanding during the period, less any shares subject to repurchase or forfeiture. There were no shares of our Common Stock outstanding subject to repurchase or forfeiture for the three and nine months ended September 30, 2016 and 2015.

Since we are in a net loss position, we have excluded outstanding stock options, all of which are subject to forfeiture, as well as warrants for the purchase of our Common Stock from our calculation of diluted net loss per share. The table below presents potentially dilutive securities that could affect our calculation of diluted net loss per share allocable to common stockholders for the periods presented.

	Three and Nine months ended,
	2016		2015
Stock options		20,705,923		17,414,242
Warrants		12,060,571		12,722,431
TOTAL		32,766,494		30,136,673

STOCKHOLDERS' EQUITY

9 Months Ended

Sep. 30, 2016

Stockholders' Equity Note [Abstract]

STOCKHOLDERS' EQUITY

NOTE 11 – STOCKHOLDERS’ EQUITY

Preferred Stock

At September 30, 2016, we had 10,000,000 shares of Preferred Stock, par value $0.001, authorized for issuance, of which no shares of Preferred Stock were issued or outstanding.

Common Stock

At September 30, 2016, we had 350,000,000 shares of Common Stock authorized, of which 196,580,212 shares of Common Stock were issued and outstanding.

On January 6, 2016, we entered into an underwriting agreement with Goldman Sachs & Co. and Cowen and Company, LLC, as the representatives of the several underwriters, or the Underwriters, relating to an underwritten public offering of 15,151,515 shares of our Common Stock at a public offering price of $8.25 per share. Under the terms of the underwriting agreement, we granted the Underwriters a 30-day option to purchase up to an aggregate of 2,272,727 additional shares of Common Stock, which option was exercised in full. The net proceeds to us from the offering were approximately $134.9 million, after deducting underwriting discounts and commissions and other estimated offering expenses payable by us. The offering closed on January 12, 2016 and we issued 17,424,242 shares of our Common Stock.

On July 9, 2015, we entered into an underwriting agreement with Stifel, Nicolaus & Company, Incorporated and Guggenheim Securities, LLC, as the representatives of the several underwriters, or the Stifel Underwriters, relating to an underwritten public offering of 3,846,154 shares of Common Stock at a public offering price of $7.80 per share. Under the terms of the underwriting agreement, we granted the Stifel Underwriters a 30-day option to purchase up to an aggregate of 576,923 additional shares of Common Stock, which option was exercised in full. The net proceeds to us from the offering were approximately $32.2 million, after deducting underwriting discounts and commissions and other estimated offering expenses payable by us. The offering closed on July 15, 2015 and we issued 4,423,077 shares of our Common Stock.

On February 10, 2015, we entered into an underwriting agreement, or the Cowen Agreement, with Cowen and Company, LLC, as the representative of the several underwriters, or the Cowen Underwriters, relating to an underwritten public offering of 13,580,246 shares of Common Stock, at a public offering price of $4.05 per share. Under the terms of the Cowen Agreement, we granted the Cowen Underwriters a 30-day option to purchase up to an aggregate of 2,037,036 additional shares of Common Stock, which option was exercised in full. The net proceeds to us from the offering were approximately $59.1 million, after deducting underwriting discounts and commissions and other estimated offering expenses payable by us. The offering closed on February 17, 2015 and we issued 15,617,282 shares of our Common Stock.

Exercises During 2016

During the three months ended September 30, 2016, certain individuals exercised stock options to purchase 127,109 shares of Common Stock. Stock options to purchase shares of Common Stock were exercised as follows: (i) 10,000 options for $1,018 in cash and (ii) 117,109 options, pursuant to the stock options’ cashless provision, wherein 78,017 shares of Common Stock were issued. During the nine months ended September 30, 2016, certain individuals exercised stock options to purchase 544,277 shares of Common Stock. Stock options to purchase shares of Common Stock were exercised as follows: (i) 427,168 options for $979,060 in cash and (ii) 117,109 options, pursuant to the stock options’ cashless provision, wherein 78,017 shares of Common Stock were issued.

Exercises During 2015

During the three months ended September 30, 2015, certain individuals exercised stock options to purchase 95,000 shares of Common Stock for $98,478 in cash. During the nine months ended September 30, 2015, certain individuals exercised stock options to purchase 472,867 shares of Common Stock for $589,829 in cash.

Warrants to Purchase Common Stock

As of September 30, 2016, we had warrants outstanding to purchase an aggregate of 12,060,571 shares of Common Stock with a weighted-average contractual remaining life of 1.3 years, and exercise prices ranging from $0.24 to $8.20 per share, resulting in a weighted average exercise price of $2.08 per share.

The valuation methodology used to determine the fair value of our warrants is the Black-Scholes-Merton valuation model, or the Black-Scholes Model. The Black-Scholes Model requires the use of a number of assumptions, including volatility of the stock price, the risk-free interest rate and the term of the warrant.

During the three months ended September 30, 2016 and 2015, we did not issue any warrants. During the nine months ended September 30, 2016, we granted warrants to purchase 245,000 shares of Common Stock to outside consultants at a weighted average exercise price of $7.90 per share. The weighted average grant date fair value of these warrants was $4.78 per share. The fair value for these warrants was determined by using the Black-Scholes Model on the date of the grant using a term of five years; volatility of 74.10%-74.15%; risk free rate of 1.04%-1.28%; and dividend yield of 0%. These warrants vest and have expiration dates as follows: warrants to purchase 75,000 shares of Common Stock vested on April 21, 2016 and have an expiration date of April 21, 2021, warrants to purchase 50,000 shares of Common Stock vest ratably over a 24-month period and have an expiration date of April 21, 2021, and warrants to purchase 120,000 shares of Common Stock vest ratable over a 12-month period and have an expiration date of January 21, 2021. During the nine months ended September 30, 2015, we granted warrants to purchase 50,000 shares of Common Stock to an outside consultant at an exercise price of $6.35 and the expiration date of April 6, 2020. We recorded share-based compensation expense related to these warrants totaling $137,161 and $42,266 for the three months ended September 30, 2016 and 2015, respectively, and $820,751 and $86,008 for the nine months ended September 30, 2016 and 2015, respectively, in the accompanying consolidated financial statements.

In May 2013, we entered into a consulting agreement to develop drug platforms to be used in our hormone replacement drug candidates. As consideration under the agreement, we agreed to issue the consultant a warrant to purchase 850,000 shares of our Common Stock at $2.01 per share that has vested or will vest as follows:

Warrants to purchase 283,333 shares were earned on May 11, 2013 upon acceptance of an Investigational New Drug application by FDA for an estradiol-based drug candidate in a softgel vaginal capsule for the treatment of VVA; however, pursuant to the terms of the agreement, the shares did not vest until June 30, 2013;

Warrants to purchase 283,333 shares vested on June 30, 2013. The fair value of $462,196 for these shares was determined by using the Black-Scholes Model on the date of the vesting using a term of five years; a volatility of 45.84%; risk free rate of 1.41%; and a dividend yield of 0%. During the three months ended September 30, 2016 and 2015, we recorded share-based compensation expense of $0 and $38,517, respectively, related to these warrants and during the nine months ended September 30, 2016 and 2015, we recorded $77,026 and $115,551, respectively, related to these warrants in the accompanying consolidated financial statements. As of June 30, 2016, the fair value of these warrants has been fully amortized;

Warrants to purchase 283,334 shares will vest upon the receipt by us of any final FDA approval of a drug candidate which the warrant holder helped us design. It is anticipated that this event will not occur before March 31, 2017.

In addition, during both the three months ended September 30, 2016 and 2015, we recorded share-based compensation expense of $64,449 and during both the nine months ended September 30, 2016 and 2015, we recorded share-based compensation expense of $193,347 related to warrants issued in 2012 for services in support of our drug development efforts. As of September 30, 2016, unamortized costs associated with warrants issued to the same holder in 2012 and 2013 totaled approximately $193,347 and will be recognized over a period of nine months.

During the three months ended September 30, 2016, no warrants were exercised and during the three months ended September 30, 2015, certain individuals and an entity exercised warrants to purchase 310,000 shares of Common Stock pursuant to the warrants’ cashless exercise provisions, wherein 232,197 shares of Common Stock were issued. During the nine months ended September 30, 2016, certain individuals exercised warrants to purchase 722,744 shares of our Common Stock for $1,373,000 in cash and during the nine months ended September 30, 2015, certain individuals and an entity exercised warrants to purchase 1,255,485 shares of Common Stock as follows: (i) 945,485 shares of Common Stock were issued for $366,000 in cash and (ii) warrants to purchase 310,000 shares of Common Stock were exercised pursuant to the warrants’ cashless exercise provisions, wherein 232,197 shares of Common Stock were issued.

Options to Purchase Common Stock

In 2009, we adopted the 2009 Long Term Incentive Compensation Plan, or the 2009 Plan, to provide financial incentives to employees, directors, advisers, and consultants of our company who are able to contribute towards the creation of or who have created stockholder value by providing them stock options and other stock and cash incentives, or the Awards. The Awards available under the 2009 Plan consist of stock options, stock appreciation rights, restricted stock, restricted stock units, performance stock, performance units, and other stock or cash awards as described in the 2009 Plan. There are 25,000,000 shares authorized for issuance thereunder. During the nine months ended September 30, 2016, we granted 557,500 non-qualified stock options under the 2009 Plan. As of September 30, 2016, there were non-qualified stock options to purchase 17,837,449 shares of Common Stock outstanding and stock options to purchase 3,122,069 shares of Common Stock available to be issued under 2009 Plan.

In 2012, we adopted the 2012 Stock Incentive Plan, or the 2012 Plan, a non-qualified plan that was amended in August 2013. The 2012 Plan was designed to serve as an incentive for retaining qualified and competent key employees, officers, directors, and certain consultants and advisors of our company. There are 10,000,000 shares of Common Stock authorized for issuance thereunder. As of September 30, 2016, there were non-qualified stock options to purchase 2,868,474 shares of Common Stock outstanding and stock options to purchase 7,050,000 shares of Common Stock available to be issued under 2012 Plan.

The valuation methodology used to determine the fair value of stock options is the Black-Scholes Model. The Black-Scholes Model requires the use of a number of assumptions including volatility of the stock price, the risk-free interest rate, and the expected life of the stock options. The assumptions used in the Black-Scholes Model for options granted during the nine months ended September 30, 2016 and 2015 are set forth in the table below.

	Nine Months Ended September 30,
	2016			2015
Risk-free interest rate		1.13-1.70	%		1.47-1.54	%
Volatility		70.26-71.22	%		58.77-62.94	%
Term (in years)		6.00-6.25			5.27-6.25
Dividend yield		0.00	%		0.00	%

The risk-free interest rate assumption is based upon observed interest rates on zero coupon U.S. Treasury bonds whose maturity period is appropriate for the expected term. Estimated volatility is a measure of the amount by which the price of our Common Stock is expected to fluctuate each year during the term of an award. Our estimated volatility is an average of the historical volatility of the stock prices of our peer entities whose stock prices were publicly available. Our calculation of estimated volatility is based on historical stock prices over a period equal to the term of the awards. We used the historical volatility of our peer entities due to the lack of sufficient historical data on our stock price. The expected term is based on the contractual terms of the stock option using the simplified method.

A summary of activity under the 2009 and 2012 Plans and related information follows:

	Number of Shares Underlying Stock Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Life in Years		Aggregate Intrinsic Value
Balance at December 31, 2015		20,725,325		$	3.28		6.5	$	146,864,184
Granted		557,500		$	7.37
Exercised		(544,277	)	$	2.27			$	3,100,742
Expired/Forfeited		(32,625	)	$	6.22
Balance at September 30, 2016		20,705,923		$	3.42		5.8	$	77,940,710
Vested and Exercisable at September 30, 2016		17,336,805		$	2.69		5.2	$	75,393,944
Unvested at September 30, 2016		3,369,118		$	7.17		8.8	$	2,546,766

At September 30, 2016, our outstanding stock options had exercise prices ranging from $0.10 to $8.92 per share. The weighted average grant date fair value per share of options granted was $4.70 and $3.49 during the nine months ended September 30, 2016 and 2015, respectively. Share-based compensation expense for options recognized in our results of operations is based on vested awards. Share-based compensation expense related to options for the three months ended September 30, 2016 and 2015 was $3,982,759 and $1,626,862, respectively, and $12,294,089 and $4,328,964, for the nine months ended September 30, 2016 and 2015, respectively. We estimate forfeitures at the time of grant and revise the forfeiture rate in subsequent periods if actual forfeitures differ from the estimates. At September 30, 2016, total unrecognized estimated compensation expense related to unvested options granted prior to that date was approximately $10,225,000 which may be adjusted for future changes in forfeitures. This cost is expected to be recognized over a weighted-average period of 2.11 years. No tax benefit was realized due to a continued pattern of operating losses.

- Definition

The entire disclosure for shareholders' equity comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income. Includes, but is not limited to, balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings, accumulated balance for each classification of other comprehensive income and amount of comprehensive income.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef
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-Name Accounting Standards Codification
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-Name Accounting Standards Codification
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Reference 3: http://www.xbrl.org/2003/role/presentationRef
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Reference 4: http://www.xbrl.org/2003/role/presentationRef
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Reference 6: http://www.xbrl.org/2003/role/presentationRef
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Reference 7: http://www.xbrl.org/2003/role/presentationRef
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Reference 8: http://www.xbrl.org/2003/role/presentationRef
-Publisher FASB
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Reference 9: http://www.xbrl.org/2003/role/presentationRef
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-Name Accounting Standards Codification
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Reference 10: http://www.xbrl.org/2003/role/presentationRef
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-Name Accounting Standards Codification
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-SubTopic 10
-Section S99
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-Name Accounting Standards Codification
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Reference 12: http://www.xbrl.org/2003/role/presentationRef
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Reference 13: http://www.xbrl.org/2003/role/presentationRef
-Publisher FASB
-Name Accounting Standards Codification
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-URI http://asc.fasb.org/extlink&oid=6928386&loc=d3e21475-112644

Reference 14: http://www.xbrl.org/2003/role/presentationRef
-Publisher FASB
-Name Accounting Standards Codification
-Glossary Preferred Stock
-URI http://asc.fasb.org/extlink&oid=6521494

Reference 15: http://www.xbrl.org/2003/role/presentationRef
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-Name Accounting Standards Codification
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+ Details

INCOME TAXES

9 Months Ended

Sep. 30, 2016

Income Tax Disclosure [Abstract]

INCOME TAXES

NOTE 12 – INCOME TAXES

Deferred income tax assets and liabilities are determined based upon differences between the financial reporting and tax basis of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. We do not expect to pay any significant federal or state income tax for 2016 as a result of (i) the losses recorded during the nine months ended September 30, 2016, (ii) additional losses expected for the remainder of 2016, and/or (iii) net operating loss carry forwards from prior years. Accounting standards require the consideration of a valuation allowance for deferred tax assets if it is “more likely than not” that some component or all of the benefits of deferred tax assets will not be realized. As of September 30, 2016, we maintain a full valuation allowance for all deferred tax assets. Based on these requirements, no provision or benefit for income taxes has been recorded. There were no recorded unrecognized tax benefits at the end of the reporting period.

RELATED PARTIES

9 Months Ended

Sep. 30, 2016

RELATED PARTIES

NOTE 13 – RELATED PARTIES

In July 2015, J. Martin Carroll, a director of our Company, was appointed to the board of directors of Catalent, Inc. From time to time, we have entered into agreements with Catalent, Inc. and its affiliates, (“Catalent”), in the normal course of business. Agreements with Catalent have been reviewed by independent directors of our Company or a committee consisting of independent directors of our Company since July 2015. During the three and nine months ended September 30, 2016, the amounts billed by Catalent were $828,062 and $2,906,838, respectively for manufacturing activities related to our clinical trials. As of September 30, 2016, there were amounts due to Catalent of $208,233.

BUSINESS CONCENTRATIONS

9 Months Ended

Sep. 30, 2016

Risks and Uncertainties [Abstract]

BUSINESS CONCENTRATIONS

NOTE 14 - BUSINESS CONCENTRATIONS

We purchase our products from several suppliers with approximately 97% and 54% of our purchases supplied from one vendor for the nine months ended September 30, 2016 and 2015, respectively.

We sell our prescription prenatal vitamin products to wholesale distributors, specialty pharmacies, specialty distributors, and chain drug stores that generally sell products to retail pharmacies, hospitals, and other institutional customers. Revenue generated from major customers accounted for approximately 60% of our recognized revenue for the nine months ended September 30, 2016 and revenue generated from major customers accounted for approximately 90% of our recognized revenue for the nine months ended September 30, 2015. Customers that generated more than 10% of our sales are designated as customers “A”, “B”, “C” and “D”. During the nine months ended September 30, 2016, four customers each generated more than 10% of our total revenues and during the nine months ended September 30, 2015, two customers each generated more than 10% of our total revenues. During the nine months ended September 30, 2016, customers A, B, C and D generated approximately $2,247,000, $1,890,000, $2,683,000 and $2,113,000, in revenues, respectively. During the nine months ended September 30, 2015, customers A and B generated approximately $6,930,000 and $3,005,000, in revenues, respectively. During the three months ended September 30, 2016, we centralized our distribution channel for both our retail pharmacies and wholesale partners. We also wrote off accounts receivable balances of approximately $2,200,000 related to two former customers mentioned above due to our inability to collect the outstanding balances.

COMMITMENTS AND CONTINGENCIES

9 Months Ended

Sep. 30, 2016

Commitments and Contingencies Disclosure [Abstract]

COMMITMENTS AND CONTINGENCIES

NOTE 15 – COMMITMENTS AND CONTINGENCIES

We lease administrative office space in Boca Raton, Florida pursuant to a non-cancelable operating lease that commenced on July 1, 2013 and originally provided for a 63-month term. On February 18, 2015, we entered into an agreement with the same lessors to lease additional administrative office space in the same location, pursuant to an addendum to such lease. In addition, on April 26, 2016, we entered into agreement with the same lessors to lease additional administrative office space in the same location. This agreement was effective beginning May 1, 2016 and extended the original expiration of the lease term to October 31, 2021.

The rental expense related to our lease during the three months ended September 30, 2016 and 2015 was approximately $182,000 and $119,000, respectively. The rental expense related to our lease during the nine months ended September 30, 2016 and 2015 was approximately $482,000 and $328,000, respectively.

As of September 30, 2016, future minimum rental payments are as follows:

Years Ending December 31,
2016 (3 months)	$	152,278
2017		600,236
2018		673,236
2019		810,234
2020		824,268
Thereafter		698,421
Total minimum lease payments	$	3,758,673

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)

9 Months Ended

Sep. 30, 2016

Accounting Policies [Abstract]

Fair Value of Financial Instruments

Level 1

unadjusted quoted prices in active markets for identical assets or liabilities;

Level 2

Level 3

unobservable inputs for the asset or liability.

Revenue Recognition

Over-the-Counter Products

Prescription Products

Share-Based Compensation

Research and Development Expenses

Segment Reporting

INVENTORY (Tables)

9 Months Ended

Sep. 30, 2016

Inventory Disclosure [Abstract]

Schedule of inventory

Inventory consists of the following:

	September 30, 2016		December 31, 2015
Finished product	$	816,400	$	661,167
Raw material		26,998		28,986
TOTAL INVENTORY	$	843,398	$	690,153

FIXED ASSETS, NET (Tables)

9 Months Ended

Sep. 30, 2016

Property, Plant and Equipment [Abstract]

Schedule of fixed assets

Fixed assets consist of the following:

	September 30, 2016			December 31, 2015
Accounting system	$	296,746		$	149,699
Equipment		164,013			132,150
Computer hardware		80,211			—
Furniture and fixtures		80,158			69,454
Leasehold improvements		37,888			—
		659,016			351,303
Accumulated depreciation		(198,470	)		(152,711	)
TOTAL FIXED ASSETS, NET	$	460,546		$	198,592

INTANGIBLE ASSETS, NET (Tables)

9 Months Ended

Sep. 30, 2016

Intangible Assets, Net (Excluding Goodwill) [Abstract]

Schedule of intangible assets

The following table sets forth the gross carrying amount and accumulated amortization of our intangible assets as of September 30, 2016 and December 31, 2015:

	September 30, 2016
	Gross Carrying Amount		Accumulated Amortization			Net Amount		Weighted- Average Remaining Amortization Period (yrs.)
Amortizing intangible assets:
OPERA^®software patent	$	31,951	$	(5,991	)	$	25,960		13
Development costs of corporate website		91,743		(91,743	)		—		n/a
Approved hormone therapy drug candidate patents		959,059		(86,907	)		872,152		16.25
Hormone therapy drug candidate patents (pending)		1,037,829		—			1,037,829		n/a
Non-amortizing intangible assets:
Multiple trademarks		182,437		—			182,437		indefinite
TOTAL	$	2,303,019	$	(184,641	)	$	2,118,378

	December 31, 2015
	Gross Carrying Amount		Accumulated Amortization			Net Amount		Weighted- Average Remaining Amortization Period (yrs.)
Amortizing intangible assets:
OPERA^®software patent	$	31,951	$	(4,493	)	$	27,458		13.75
Development costs of corporate website		91,743		(91,743	)		—		n/a
Approved hormone therapy drug candidate patents		705,752		(49,845	)		655,907		17
Hormone therapy drug candidate patents (pending)		774,165		—			774,165		n/a
Non-amortizing intangible assets:
Multiple trademarks		157,721		—			157,721		indefinite
TOTAL	$	1,761,332	$	(146,081	)	$	1,615,251

Schedule of estimated amortization expense

Estimated amortization expense for the next five years is as follows:

Year Ending December 31,		Estimated Amortization
	2016 (3 months)	$	13,917
	2017	$	55,668
	2018	$	55,668
	2019	$	55,668
	2020	$	55,668

NET LOSS PER SHARE (Tables)

9 Months Ended

Sep. 30, 2016

Earnings Per Share [Abstract]

Schedule of potentially dilutive securities

The table below presents potentially dilutive securities that could affect our calculation of diluted net loss per share allocable to common stockholders for the periods presented.

	Three and Nine months ended,
	2016		2015
Stock options		20,705,923		17,414,242
Warrants		12,060,571		12,722,431
TOTAL		32,766,494		30,136,673

STOCKHOLDERS' EQUITY (Tables)

9 Months Ended

Sep. 30, 2016

Stockholders' Equity Note [Abstract]

Schedule of assumptions used in the Black-Scholes Model of stock options

The assumptions used in the Black-Scholes Model for options granted during the nine months ended September 30, 2016 and 2015 are set forth in the table below.

	Nine Months Ended September 30,
	2016			2015
Risk-free interest rate		1.13-1.70	%		1.47-1.54	%
Volatility		70.26-71.22	%		58.77-62.94	%
Term (in years)		6.00-6.25			5.27-6.25
Dividend yield		0.00	%		0.00	%

Schedule of plan activity

A summary of activity under the 2009 and 2012 Plans and related information follows:

	Number of Shares Underlying Stock Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Life in Years		Aggregate Intrinsic Value
Balance at December 31, 2015		20,725,325		$	3.28		6.5	$	146,864,184
Granted		557,500		$	7.37
Exercised		(544,277	)	$	2.27			$	3,100,742
Expired/Forfeited		(32,625	)	$	6.22
Balance at September 30, 2016		20,705,923		$	3.42		5.8	$	77,940,710
Vested and Exercisable at September 30, 2016		17,336,805		$	2.69		5.2	$	75,393,944
Unvested at September 30, 2016		3,369,118		$	7.17		8.8	$	2,546,766

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative)	9 Months Ended
	Sep. 30, 2016 USD ($) Number	Dec. 31, 2015 USD ($)
Shelf life of prescription products	24 months
Number of operating segment \| Number	1
Related to Research and Development Activities [Member]
Advance payments - total	$ 244,335	$ 1,138,073
Advance payments - other assets current		1,009,175
Advance payments - long term prepaid expense		$ 128,898
Minimum [Member]
Return period of unsalable prescription products	6 months
Maximum [Member]
Return period of unsalable prescription products	12 months

INVENTORY (Details) - USD ($)	Sep. 30, 2016	Dec. 31, 2015
Inventory
Finished product	$ 816,400	$ 661,167
Raw material	26,998	28,986
TOTAL INVENTORY	$ 843,398	$ 690,153

OTHER CURRENT ASSETS (Details) - USD ($)	Sep. 30, 2016	Dec. 31, 2015
Other Current Assets
Prepaid insurance	$ 842,020	$ 695,421
Prepaid manufacturing costs	988,835
Prepaid consulting	193,347	334,822
Other prepaid costs	318,407	369,812
Prepaid vendor deposits	299,878	159,489
Prepaid research and development costs	50,988	674,353
TOTAL OTHER CURRENT ASSETS	$ 2,693,475	$ 2,233,897

FIXED ASSETS, NET (Details) - USD ($)	Sep. 30, 2016	Dec. 31, 2015
Fixed assets, gross	$ 659,016	$ 351,303
Accumulated depreciation	(198,470)	(152,711)
TOTAL FIXED ASSETS, NET	460,546	198,592
Accounting System [Member]
Fixed assets, gross	296,746	149,699
Equipment [Member]
Fixed assets, gross	164,013	132,150
Furniture and Fixtures [Member]
Fixed assets, gross	80,158	$ 69,454
Computer Hardware [Member]
Fixed assets, gross	80,211
Leasehold Improvements [Member]
Fixed assets, gross	$ 37,888

PREPAID EXPENSE (Details) - USD ($)	Sep. 30, 2016	Dec. 31, 2015
Prepaid Expense
Prepaid manufacturing costs		$ 980,985
Prepaid research and development costs		128,898
TOTAL PREPAID EXPENSE		$ 1,109,883

INTANGIBLE ASSETS, NET (Details Narrative)	3 Months Ended		9 Months Ended
INTANGIBLE ASSETS, NET (Details Narrative)	Sep. 30, 2016 USD ($) Number	Sep. 30, 2015 USD ($)	Sep. 30, 2016 USD ($) Number	Sep. 30, 2015 USD ($)
Amortization expense \| $	$ 13,917	$ 8,692	$ 38,560	$ 22,296
Number of issued patents	17		17
Hormone Therapy Drug Candidate Patents - (Pending) [Member]
Useful Life			16 years
Opera Software Patent [Member]
Useful Life			13 years
Number of issued patents	1		1
Approved Hormone Therapy Drug Candidate Patents [Member]
Useful Life			20 years
Utility Patent Progesterone and Estradiol Products [Member]
Number of issued patents	13		13
Utility Patent TX-004HR [Member]
Number of issued patents	2		2
Utility Patent Pipeline Transdermal Patch Technology [Member]
Number of issued patents	1		1

INTANGIBLE ASSETS, NET (Details) - USD ($)	9 Months Ended	12 Months Ended
INTANGIBLE ASSETS, NET (Details) - USD ($)	Sep. 30, 2016	Dec. 31, 2015
Finite-Lived Intangible Assets
Accumulated Amortization	$ (184,641)	$ (146,081)
Indefinite-Lived Intangible Assets
Gross Carrying Amount	2,303,019	1,761,332
Net Amount	2,118,378	1,615,251
Hormone Therapy Drug Candidate Patents - (Pending) [Member]
Finite-Lived Intangible Assets
Gross Carrying Amount	1,037,829	774,165
Net Amount	1,037,829	774,165
Multiple Trademarks [Member]
Indefinite-Lived Intangible Assets
Gross Carrying Amount	182,437	157,721
Net Amount	182,437	157,721
Opera Software Patent [Member]
Finite-Lived Intangible Assets
Gross Carrying Amount	31,951	31,951
Accumulated Amortization	(5,991)	(4,493)
Net Amount	$ 25,960	$ 27,458
Weighted average remaining amortization period	13 years	13 years 9 months
Development Costs Of Corporate Website [Member]
Finite-Lived Intangible Assets
Gross Carrying Amount	$ 91,743	$ 91,743
Accumulated Amortization	(91,743)	(91,743)
Approved Hormone Therapy Drug Candidate Patents [Member]
Finite-Lived Intangible Assets
Gross Carrying Amount	959,059	705,752
Accumulated Amortization	(86,907)	(49,845)
Net Amount	$ 872,152	$ 655,907
Weighted average remaining amortization period	16 years 3 months	17 years

INTANGIBLE ASSETS, NET (Details 1)	Sep. 30, 2016 USD ($)
Estimated amortization expense for the year:
2016 (3 months)	$ 13,917
2017	55,668
2018	55,668
2019	55,668
2020	$ 55,668

OTHER CURRENT LIABILITIES (Details) - USD ($)	Sep. 30, 2016	Dec. 31, 2015
Other Liabilities Disclosure [Abstract]
Accrued clinical trial costs	$ 3,778,784	$ 3,725,377
Accrued payroll, bonuses and commission costs	1,622,333	2,108,143
Accrued compensated absences	772,958	562,096
Accrued legal and accounting expense	377,172	210,309
Accrued sales and marketing costs	617,961
Other accrued expenses	231,037	546,264
Allowance for wholesale distributor fees	100,434	32,659
Accrued royalties	27,495	46,851
Allowance for coupons and returns	564,864	224,300
Accrued rent	150,383	83,527
TOTAL OTHER CURRENT LIABILITIES	$ 8,243,421	$ 7,539,526

NET LOSS PER SHARE (Details) - shares	3 Months Ended		9 Months Ended
NET LOSS PER SHARE (Details) - shares	Sep. 30, 2016	Sep. 30, 2015	Sep. 30, 2016	Sep. 30, 2015
Anti-dilutive shares excluded from earnings per share calculation	32,766,494	30,136,673	32,766,494	30,136,673
Warrants [Member]
Anti-dilutive shares excluded from earnings per share calculation	12,060,571	12,722,431	12,060,571	12,722,431
Stock Options [Member]
Anti-dilutive shares excluded from earnings per share calculation	20,705,923	17,414,242	20,705,923	17,414,242

STOCKHOLDERS' EQUITY (Details Narrative) - USD ($)							3 Months Ended		9 Months Ended
STOCKHOLDERS' EQUITY (Details Narrative) - USD ($)	Jan. 12, 2016	Jan. 06, 2016	Jul. 15, 2015	Jul. 09, 2015	Feb. 17, 2015	Feb. 10, 2015	Sep. 30, 2016	Sep. 30, 2015	Sep. 30, 2016	Sep. 30, 2015	Dec. 31, 2015
Preferred stock, par value (in dollars per share)							$ 0.001		$ 0.001		$ 0.001
Preferred stock, shares authorized							10,000,000		10,000,000		10,000,000
Preferred stock, shares issued							0		0		0
Preferred stock, shares outstanding							0		0		0
Common stock, shares authorized							350,000,000		350,000,000		350,000,000
Common stock, shares issued							196,580,212		196,580,212		177,928,041
Common stock, shares outstanding							196,580,212		196,580,212		177,928,041
2009 Long-term Incentive Plan [Member]
Weighted average grant date fair value							$ 4.70		$ 4.70
Number of shares authorized for issuance							25,000,000		25,000,000
Options outstanding, ending							17,837,449		17,837,449
Number of shares available for issuance							3,122,069		3,122,069
2012 Stock Incentive Plan [Member]
Number of shares authorized for issuance							10,000,000		10,000,000
Options outstanding, ending							2,868,474		2,868,474
Number of shares available for issuance							7,050,000		7,050,000
Stock Options [Member]
Weighted average grant date fair value								$ 3.49		$ 3.49
Exercise price - lower									$ 0.10
Exercise price - upper									$ 8.92
Sharebased compensation - stock options							$ 3,982,759	$ 1,626,862	$ 12,294,089	$ 4,328,964
Unrecognized estimated compensation expense							$ 10,225,000		$ 10,225,000
Recognized period for recognition - stock option compensation									2 years 1 month 10 days
Total Stock Options [Member]
Common stock issued during period for stock options exercised, shares							127,109
Stock Options Cash Exercise [Member]
Common stock issued during period for stock options exercised, shares							10,000	95,000	427,168	472,867
Common stock issued during period for stock options exercised							$ 1,018	$ 98,474	$ 979,060	$ 589,829
Stock Options Cashless Exercise [Member]
Common stock issued during period for stock options exercised, shares							78,017		78,017
Options exercised - cashless							117,109		117,109
Underwriting Agreement - Goldman And Cowen [Member]
Number of shares issued during the period	17,242,242	15,151,515
Share price (in dollars per share)		$ 8.25
Common stock issued during the period		$ 134,900,000
Additional common stock issued under offering		2,272,727
Number of days of the option to purchase shares		30 days
Stifel Underwriters [Member]
Number of shares issued during the period			4,423,077	3,846,154
Share price (in dollars per share)				$ 7.80
Common stock issued during the period				$ 32,200,000
Additional common stock issued under offering				576,923
Number of days of the option to purchase shares				30 days
Cowen and Company, LLC (Underwriters) [Member]
Number of shares issued during the period					15,617,282	13,580,246
Share price (in dollars per share)						$ 4.05
Common stock issued during the period						$ 59,100,000
Additional common stock issued under offering						2,037,036
Number of days of the option to purchase shares						30 days

STOCKHOLDERS' EQUITY (Details Narrative 1) - USD ($)		1 Months Ended	3 Months Ended		9 Months Ended		35 Months Ended
STOCKHOLDERS' EQUITY (Details Narrative 1) - USD ($)	May 11, 2013	Jun. 30, 2013	Sep. 30, 2016	Sep. 30, 2015	Sep. 30, 2016	Sep. 30, 2015	Sep. 30, 2016
Warrants:
Warrants outstanding			$ 12,060,571		$ 12,060,571		$ 12,060,571
Weighted-average contractual remaining life					1 year 3 months 12 days
Share based compensation expense					$ 13,385,215	$ 4,740,906
Outside Consultant Warrants [Member]
Warrants:
Share based compensation expense			$ 137,161	$ 42,266	$ 820,751	$ 86,008
Outside Consultant Warrants [Member] \| Tranche One [Member]
Warrants:
Expiration date of warrants			Apr. 21, 2021
Vesting date of warrants			Apr. 21, 2016
Vesting date of warrants			24 months
Outside Consultant Warrants [Member] \| Tranche Two [Member]
Warrants:
Expiration date of warrants			Apr. 21, 2021
Vesting date of warrants			24 months
Outside Consultant Warrants #2 [Member]
Warrants:
Warrants granted (shares)					245,000
Grant date fair value (in dollars per share)					$ 4.78
Expected term					5 years
Dividend yield					0.00%
Weighted average exercise price of warrants					$ 7.90
Outside Consultant Warrants #2 [Member] \| Tranche One [Member]
Warrants:
Warrants granted (shares)					75,000
Expiration date of warrants					Apr. 21, 2021
Vesting date of warrants					Apr. 21, 2016
Outside Consultant Warrants #2 [Member] \| Tranche Two [Member]
Warrants:
Warrants granted (shares)					50,000
Expiration date of warrants					Apr. 21, 2021
Vesting date of warrants					24 months
Outside Consultant Warrants #2 [Member] \| Tranche Three [Member]
Warrants:
Warrants granted (shares)					120,000
Expiration date of warrants					Jan. 21, 2021
Vesting date of warrants					12 months
Outside Consultant Warrants #3 [Member]
Warrants:
Exercise price of warrants (in dollars per share)				$ 6.35		$ 6.35
Warrants granted (shares)				50,000		50,000
Expiration date of warrants				Apr. 06, 2020
Consultant Agreement - Warrants [Member]
Warrants:
Exercise price of warrants (in dollars per share)	$ 2.01
Warrants granted (shares)	283,333	283,333					850,000
Fair value of grant		$ 462,196
Share based compensation expense			$ 0	$ 38,517	$ 77,026	$ 115,551
Expected term		5 years
Volatility rate		45.84%
Risk free rate		1.41%
Dividend yield		0.00%
Expected to vested warrants upon FDA approval (in shares)			283,334		283,334		283,334
Unamortized noncash compensation associated with warrants			$ 193,347		$ 193,347		$ 193,347
Warrants [Member]
Warrants:
Share based compensation expense			$ 64,449	$ 64,449	$ 193,347	$ 193,347
Weighted average exercise price of warrants					$ 2.08
Stock issued for excercised warrants, shares					722,744	945,485
Stock issued for excercised warrants					$ 1,373,000	$ 366,000
Warrants - Cashless Exercise [Member]
Warrants:
Stock issued for excercised warrants, shares				232,197		232,197
Warrants exercised				310,000		310,000
Total Warrants Exercised [Member]
Warrants:
Warrants exercised						1,255,485
Minimum [Member] \| Outside Consultant Warrants #2 [Member]
Warrants:
Volatility rate					74.10%
Risk free rate					1.04%
Maximum [Member] \| Outside Consultant Warrants #2 [Member]
Warrants:
Volatility rate					74.15%
Risk free rate					1.28%
Warrants [Member] \| Minimum [Member]
Warrants:
Exercise price of warrants (in dollars per share)			$ 0.24		$ 0.24		$ 0.24
Warrants [Member] \| Maximum [Member]
Warrants:
Exercise price of warrants (in dollars per share)			$ 8.20		$ 8.20		$ 8.20

STOCKHOLDERS' EQUITY (Details) - Stock Options [Member]	9 Months Ended
STOCKHOLDERS' EQUITY (Details) - Stock Options [Member]	Sep. 30, 2016	Sep. 30, 2015
Dividend yield	0.00%	0.00%
Minimum [Member]
Risk-free interest rate	1.13%	1.47%
Volatility	70.26%	58.77%
Term	6 years	5 years 3 months 7 days
Maximum [Member]
Risk-free interest rate	1.70%	1.54%
Volatility	71.22%	62.94%
Term	6 years 3 months	6 years 3 months

STOCKHOLDERS' EQUITY (Details 1) - 2009 and 2012 Plans [Member] - USD ($)	9 Months Ended
	Sep. 30, 2016	Sep. 30, 2015
Share-based Compensation Arrangement Options, Number of Shares
Options outstanding, beginning	20,725,325
Options Granted	557,500
Options Exercised	(544,277)
Options Expired/Forfeited	(32,625)
Options outstanding, ending	20,705,923
Vested and exercisable	17,336,805
Unvested	3,369,118
Share-based Compensation Arrangement Options, Weighted Average Exercise Price
Options outstanding, beginning	$ 3.28
Granted	7.37
Exercised	2.27
Expired/Forfeited	6.22
Options outstanding, ending	3.42
Vested and exercisable	2.69
Unvested	$ 7.17
Share-based Compensation Arrangement Options, Weighted Average Remaining Contractual Life
Options outstanding	6 years 6 months	5 years 9 months 18 days
Vested and exercisable	5 years 2 months 12 days
Unvested	8 years 9 months 18 days
Share-based Compensation Arrangement Options, Aggregate Intrinsic Value
Options outstanding, beginning	$ 146,864,184
Options exercised	3,100,742
Options outstanding, ending	77,940,710
Vested and exercisable	75,393,944
Unvested	$ 2,546,766

RELATED PARTIES (Details Narrative) - Catalent Inc.[Member]	3 Months Ended	9 Months Ended
	Sep. 30, 2016 USD ($)	Sep. 30, 2016 USD ($)
Payable - related party	$ 208,233	$ 208,233
Manufacturing activities billed from related party	$ 828,062	$ 2,906,838

BUSINESS CONCENTRATIONS (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
BUSINESS CONCENTRATIONS (Details Narrative) - USD ($)	Sep. 30, 2016	Sep. 30, 2015	Sep. 30, 2016	Sep. 30, 2015
Concentration Risk [Line Items]
Revenues	$ 5,535,685	$ 5,190,175	$ 14,869,023	$ 14,513,158
Two Customers [Member]
Concentration Risk [Line Items]
Write-off accounts receivable	$ 2,200,000
Supplier Concentration Risk [Member]
Concentration Risk [Line Items]
Concentration Risk			97.00%	54.00%
Customer Concentration Risk [Member] \| Sales Revenue [Member]
Concentration Risk [Line Items]
Concentration Risk			60.00%	90.00%
Customer Concentration Risk [Member] \| Sales Revenue [Member] \| Four Customers [Member]
Concentration Risk [Line Items]
Concentration Risk			10.00%
Customer Concentration Risk [Member] \| Sales Revenue [Member] \| Two Customers [Member]
Concentration Risk [Line Items]
Concentration Risk				10.00%
Customer A [Member] \| Sales Revenue [Member]
Concentration Risk [Line Items]
Revenues			$ 2,247,000	$ 6,930,000
Customer B [Member] \| Sales Revenue [Member]
Concentration Risk [Line Items]
Revenues			1,890,000	$ 3,005,000
Customer C [Member] \| Sales Revenue [Member]
Concentration Risk [Line Items]
Revenues			2,683,000
Customer D [Member] \| Sales Revenue [Member]
Concentration Risk [Line Items]
Revenues			$ 2,113,000

COMMITMENTS AND CONTINGENCIES (Details)	Sep. 30, 2016 USD ($)
Future minimum rental payments, year ending December 31,
2016 (3 months)	$ 152,278
2017	600,236
2018	673,236
2019	810,234
2020	824,268
Thereafter	698,421
Total minimum lease payments	$ 3,758,673

COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2016	Sep. 30, 2015	Sep. 30, 2016	Sep. 30, 2015
Commitments and Contingencies Disclosure [Abstract]
Non-cancelable operating lease term			63 months
Rental expense	$ 182,000	$ 119,000	$ 482,000	$ 328,000

FIXED ASSETS, NET (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
FIXED ASSETS, NET (Details Narrative) - USD ($)	Sep. 30, 2016	Sep. 30, 2015	Sep. 30, 2016	Sep. 30, 2015
Property, Plant and Equipment [Abstract]
Depreciation expense	$ 26,543	$ 7,856	$ 45,759	$ 22,104