BOCA RATON, Fla.--(BUSINESS WIRE)--Aug. 10, 2017--
TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare
company, today announced a regulatory update regarding the New Drug
Application (NDA) for TX-004HR, the company’s investigational
applicator-free estradiol vaginal softgel capsule for the treatment of
moderate-to-severe vaginal pain during sexual intercourse (dyspareunia),
a symptom of vulvar and vaginal atrophy (VVA) due to menopause.
On July 5, 2017, the Company submitted additional endometrial safety
information to the FDA, as requested by the Agency, to address the only
approvability issue raised in the Complete Response Letter (CRL) for the
NDA for TX-004HR, which was the lack of long-term safety data beyond the
12 weeks studied in the REJOICE Trial.
The Company has received a formal General Advice Letter from the FDA
stating that an initial review of this information has been completed
and requesting that the Company submit the additional endometrial safety
information to the NDA for TX-004HR on or before September 18, 2017,
including the safety data from a very large, observational study of
long-term, real-world users of vaginal estrogens that is pending
publication.
The FDA requested approximately six weeks to perform a comprehensive
review of these data and has requested a meeting with the Company to
discuss the outcome of this review. A tentative meeting date of November
3, 2017 has been set by the Agency. At this meeting, the Company expects
to learn if this additional endometrial safety data addresses the lack
of long-term safety identified in the CRL. The Company currently plans
to re-submit the NDA for TX-004HR shortly thereafter.
“We are very pleased with the FDA’s decision to conduct this
comprehensive review and believe that the short timeline and the
resources that the FDA has committed demonstrate the significance of the
long-term observational study and other information that we provided the
Agency,” said TherapeuticsMD CEO Robert G. Finizio. “We believe this is
an important step towards the approval of our NDA for TX-004HR and we
look forward to working collaboratively with the FDA.”
The Company will host a conference call and live audio webcast to
discuss this announcement on Thursday, August 10. The conference call
and webcast will take place at 5:00 p.m. Eastern Time (ET).
TherapeuticsMD Chief Executive Officer Robert G. Finizio and Chief
Clinical Officer Dr. Brian Bernick will host the call.
Details for the call and webcast are:
Date
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Thursday, August 10, 2017`
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Time
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5:00 p.m. ET
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Telephone Access: U.S. and Canada
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866-665-9531
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Telephone Access: International
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724-987-6977
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Access Code For All Callers
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67840801
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Live Audio Webcast
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www.therapeuticsmd.com See
Home Page or “Investors & Media” Section
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Shortly after completion of the call and webcast, an audio replay will
be available for at least 30 days on the company's website, www.therapeuticsmd.com,
in the “Investors & Media” section. In addition, a digital recording of
the conference call will be available for replay beginning two hours
after the call's completion and for at least 30 days with the dial-in
855-859-2056 or international 404-537-3406 and Conference ID: 67840801.
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’s late stage clinical pipeline includes two phase 3 product
candidates: TX-001HR for treatment of moderate-to-severe vasomotor
symptoms (VMS) due to menopause and TX-004HR for treatment of
moderate-to-severe vaginal pain during sexual intercourse (dyspareunia),
a symptom of vulvar and vaginal atrophy (VVA) due to menopause. The
company also manufactures and distributes branded and generic
prescription 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: the company’s ability to resolve the deficiencies
identified by the FDA in the company’s new drug application for its
TX-004HR product candidate and the time frame associated with such
resolution; whether the company will be able to prepare an amended NDA
for its TX-004HR product candidate and, if prepared, whether the FDA
will accept and approve the NDA; 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 will be able to
prepare an NDA for its TX-001HR product candidate and, if prepared,
whether the FDA will accept and approve the NDA; the length, cost and
uncertain results of the company’s clinical trials, including any
additional clinical trials that the FDA may require in connection with
TX-004HR; the potential of adverse side effects or other safety risks
that could preclude the approval of the company’s hormone therapy drug
candidates; 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170810006098/en/
Source: TherapeuticsMD, Inc.
TherapeuticsMD, Inc.
Investor Contact
David
DeLucia, 561-961-1900
Director, Investor Relations
David.DeLucia@TherapeuticsMD.com