TherapeuticsMD Announces New Drug Application Submission for Yuvvexy™ (TX-004HR)

BOCA RATON, Fla.–(BUSINESS WIRE)–TherapeuticsMD, Inc. (NYSE MKT:TXMD), an innovative women’s healthcare
company, announced today that it has submitted its New Drug Application
(NDA) for Yuvvexy with the U.S. Food and Drug Administration (FDA). The
NDA submission is supported by the complete Yuvvexy clinical program,
including positive results of the recently completed phase 3 Rejoice
Trial. The NDA submission includes all three doses of Yuvvexy (4 mcg, 10
mcg and 25 mcg) that were evaluated in the Rejoice Trial.

Yuvvexy, the conditionally-approved trade name for the company’s
TX-004HR drug candidate, is an applicator-free, vaginal, estradiol
softgel capsule being proposed for the treatment of moderate-to-severe
vaginal pain during sexual intercourse (dyspareunia), a symptom of
vulvar and vaginal atrophy (VVA) due to menopause.

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 clinical development pipeline includes two phase 3
products. The company also manufactures and distributes branded and
generic prescription prenatal vitamins as well as over-the-counter
vitamins under the vitaMedMD® and BocaGreenMD®

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 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 FDA will accept the company’s
new drug application for its TX-004HR product candidate; 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;
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:


TherapeuticsMD, Inc.
Delucia, 561-961-1900
Director of Investor Relations