- Meeting scheduled with the FDA for November 3, 2017 -
BOCA RATON, Fla.--(BUSINESS WIRE)--Sep. 14, 2017--
TherapeuticsMD, Inc. (NYSE American: TXMD), an innovative women’s
healthcare company, today announced the submission of the additional
endometrial safety information that was requested by the Food and Drug
Administration (FDA) in its recent General Advice Letter to the Company
to the New Drug Application (NDA) for TX-004HR. The Company has
scheduled a formal meeting with the FDA for November 3, 2017, at which
the Company expects to learn if this additional endometrial safety data
addresses the lack of long-term safety identified in the Complete
Response Letter for the NDA for TX-004HR. The Company currently plans to
re-submit the NDA for TX-004HR shortly after the meeting.
The submission includes a comprehensive, systematic review of the
medical literature on the use of vaginal estrogen products and the risk
of endometrial hyperplasia or cancer, including the safety data from the
recently published Women’s Health Initiative Observational Study of
vaginal estrogen use in postmenopausal women and information on the
relevance of the first uterine pass effect for low-dose vaginal
estrogen products.
“Our comprehensive, systematic review of the medical literature on the
use of vaginal estrogen products is compelling and the totality of the
data demonstrates that these products are not associated with increased
risks of endometrial hyperplasia or cancer,” said TherapeuticsMD Chief
Clinical Officer Brian Bernick. “We believe this is an important step
towards the approval of our NDA for TX-004HR and we look forward to
meeting with the FDA in November to discuss our path forward.”
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.
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Source: TherapeuticsMD, Inc.
TherapeuticsMD, Inc.
David DeLuciam, 561-961-1900
Director,
Investor Relations
David.DeLucia@TherapeuticsMD.com