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TherapeuticsMD Announces Multiple Presentations at the International Menopause Society’s 16th World Congress

-7 Presentations at the 16thIMS World Congress on Menopause-

BOCA RATON, Fla.--(BUSINESS WIRE)--Jun. 6, 2018-- TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women’s healthcare company, today announced the schedule of seven presentations at the International Menopause Society’s 16thWorld Congress on Menopause related to clinical data for Imvexxy™ (estradiol vaginal inserts) (formerly TX-004HR), an applicator-free, ultra-low dose estradiol softgel vaginal insert, and TX-001HR, the Company’s investigational bio-identical oral combination of estradiol and progesterone for the treatment of moderate-to-severe vasomotor symptoms (VMS) due to menopause. The presentations report results from the Imvexxy and TX-001HR clinical development programs. The posters and presentations will be made at the annual meeting of the International Menopause Society being held June 6-9, 2018 in Vancouver, Canada.

“The Imvexxy presentations highlight the importance of vaginal estrogen therapy as an effective treatment option for the millions of menopausal women suffering from moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy,” said Sharon Parish, M.D., Professor of Medicine in Clinical Psychiatry and Professor of Clinical Medicine at Weill Cornell Medical College. “Imvexxy is a welcome addition in this therapeutic category due to its unique attributes, including its 4 mcg ultra-low-dose, vaginal softgel delivery mechanism, and ease of use."

Please see Important Safety Information, including boxed warning, for Imvexxy below.

“TX-001HR is the first bio-identical combination hormone therapy of estradiol and progesterone to demonstrate safety and efficacy data in a large, well-controlled, randomized clinical trial. These data support the New Drug Application filed on December 28, 2017, with a PDUFA target action date of October 28, 2018,” said Brian Bernick, M.D., Chief Clinical Officer of TherapeuticsMD.

The posters and presentations will be made available in the Investors & Media section of the company’s website at www.therapeuticsmd.com.

Details of the presentations for TX-001HR include:

Title: TX-001HR is Associated with a Clinically Meaningful Effect on Vasomotor Symptoms
Session Date/Time: Friday, June 8th, 10:50-11:20 AM PDT (poster)

Title: Effects of TX-001HR on Uterine Bleeding Rates in Menopausal Women with Vasomotor Symptoms
Session Date/Time: Saturday, June 9th, 10:00-11:30 AM PDT (slide presentation)

Title: Progesterone Bioavailability for Preventing Endometrial Stimulation with a Continuous-combined regimen of TX-001HR (oral estradiol and micronized progesterone capsules)
Session Date/Time: Saturday, June 9th, 10:00-11:30 AM PDT (slide presentation)

Title: 17β-estradiol/progesterone in a Single Oral Softgel Capsule (TX-001HR) Significantly Reduced Moderate-to-Severe Vasomotor Symptoms without Endometrial Hyperplasia
Session Date/Time: Saturday, June 9th, 10:00-11:30 AM PDT (Slide presentation)

Details of the presentations for Imvexxy (TX-004HR) include:

Title: Symptomatic Vulvar and Vaginal Atrophy (VVA) Relief was Achieved with Negligible to Very Low Systemic Absorption of Estradiol with TX-004HR, a Vaginal, Estradiol, Softgel Capsule: PK Comparison to Systemic and a Vaginal Estradiol
Session Date/Time: Friday, June 8th, 10:50-11:20 AM PDT (poster)

Title: Ultra-low Doses of TX-004HR (Estradiol Vaginal Softgel Capsule) Improve Symptoms of Vulvar and Vaginal Atrophy while Maintaining Serum Levels of Estradiol within the Normal Postmenopausal Range
Session Date/Time: Friday, June 8th, 10:50-11:20 AM PDT (poster)

Title: TX-004HR Provides Robust Improvement of Symptomatic Postmenopausal Vulvar and Vaginal Atrophy (VVA) with Negligible to Very Low Systemic Absorption of Estradiol: Results of Phase 1 and 3 Clinical Trials
Session Date/Time: Friday, June 8th, 10:50-11:20 AM PDT (poster)

IMPORTANT SAFETY INFORMATION FOR IMVEXXY

 

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA

 
See full prescribing information for complete boxed warning.
 

Estrogen-Alone Therapy

• There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens

• Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia

• The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT)

• The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older

Estrogen Plus Progestin Therapy

• Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia

• The WHI estrogen plus progestin substudy reported increased risks of stroke, DVT, pulmonary embolism (PE) and myocardial infarction (MI)

• The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer

• The WHIMS estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older

 

CONTRAINDICATIONS

  • IMVEXXY™ is contraindicated in women with any of the following conditions: undiagnosed abnormal genital bleeding; known, suspected, or history of breast cancer; known or suspected estrogen-dependent neoplasia; active DVT, PE, or history of these conditions; active arterial thromboembolic disease or a history of these conditions; known anaphylactic reaction or angioedema to IMVEXXY; known liver impairment or disease; known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.

WARNINGS AND PRECAUTIONS

  • IMVEXXY is intended only for vaginal administration. Systemic absorption may occur with the use of IMVEXXY.
  • The use of estrogen-alone and estrogen plus progestin therapy has been reported to result in an increase in abnormal mammograms requiring further evaluation.
  • The WHI estrogen plus progestin substudy reported a statistically non-significant increased risk of ovarian cancer. A meta-analysis of 17 prospective and 35 retrospective epidemiology studies found that women who used hormonal therapy for menopausal symptoms had an increased risk for ovarian cancer. The exact duration of hormone therapy use associated with an increased risk of ovarian cancer, however, is unknown.
  • Other warnings include: gallbladder disease; severe hypercalcemia, loss of vision, severe hypertriglyceridemia or cholestatic jaundice.
  • Estrogen therapy may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions.
  • Women on thyroid replacement therapy should have their thyroid function monitored.

ADVERSE REACTIONS

  • The most common adverse reaction with IMVEXXY (incidence ≥ 3 percent) and greater than placebo was headache.

Please note that this information is not comprehensive. Please visit http://imvexxy.com/pi.pdf for the Full Prescribing Information, including the Boxed Warning.

About TherapeuticsMD, Inc.

TherapeuticsMD, Inc. is an innovative healthcare company focused on developing and commercializing products exclusively for women. With its SYMBODA™ technology, TherapeuticsMD is developing advanced hormone therapy pharmaceutical products to enable delivery of bio-identical hormones through a variety of dosage forms and administration routes. The company has recently received FDA approval for TX-004HR, branded as IMVEXXY™ (estradiol vaginal inserts), for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. The company’s late stage clinical pipeline includes TX-001HR for treatment of moderate-to-severe vasomotor symptoms (VMS) due to menopause. The company also manufactures and distributes branded and generic prescription prenatal vitamins as well as over-the-counter prenatal vitamins under the vitaMedMD® and BocaGreenMD® brands.

Forward-Looking Statements

This press release by TherapeuticsMD, Inc. may contain forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to TherapeuticsMD’s objectives, plans and strategies as well as statements, other than historical facts, that address activities, events or developments that the company intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as “believes,” “hopes,” “may,” “anticipates,” “should,” “intends,” “plans,” “will,” “expects,” “estimates,” “projects,” “positioned,” “strategy” and similar expressions and are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and the company undertakes no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of the company’s control. Important factors that could cause actual results, developments and business decisions to differ materially from forward-looking statements are described in the sections titled “Risk Factors” in the company’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as reports on Form 8-K, and include the following: whether the FDA will approve the NDA for the company’s TX-001HR product candidate and whether such approval will occur by the PDUFA target action date; the company’s ability to maintain or increase sales of its products; the company’s ability to develop and commercialize its hormone therapy drug candidates and obtain additional financing necessary therefor; whether the company be able to comply with the covenants and conditions under its term loan agreement; the length, cost and uncertain results of the company’s clinical trials; the potential of adverse side effects or other safety risks that could preclude the approval of the company’s hormone therapy drug candidates or adversely affect the commercialization of the company’s current or future approved products; the company’s reliance on third parties to conduct its clinical trials, research and development and manufacturing; the availability of reimbursement from government authorities and health insurance companies for the company’s products; the impact of product liability lawsuits; the influence of extensive and costly government regulation; the volatility of the trading price of the company’s common stock and the concentration of power in its stock ownership. PDF copies of the company’s historical press releases and financial tables can be viewed and downloaded at its website: www.therapeuticsmd.com/pressreleases.aspx.

Source: TherapeuticsMD, Inc.

TherapeuticsMD, Inc.
Investor Contact:
Nichol Ochsner, 561-961-1900
Vice President, Investor Relations
nochsner@TherapeuticsMD.com