TherapeuticsMD Announces FDA Acceptance of New Drug Application (NDA) and Prescription Drug User Fee Act (PDUFA) Date for Yuvvexy™ (TX-004HR)

PDUFA target action date of May 7, 2017

BOCA RATON, Fla.–(BUSINESS WIRE)–TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare
company, today announced the acceptance of the NDA for Yuvvexy, the
conditionally-approved trade name for TX-004HR, by the U.S. Food and
Drug Administration (FDA). Yuvvexy is an investigational bio-identical
17β-estradiol vaginal softgel capsule for the treatment of
moderate-to-severe vaginal pain during sexual intercourse (dyspareunia),
a symptom of vulvar vaginal atrophy (VVA) in postmenopausal women.

The NDA acceptance by the FDA in its 74-day letter indicates that the
application is sufficiently complete to permit a substantive review. The
PDUFA target action date for the completion of the FDA’s review is May
7, 2017.

“The acceptance of the NDA for Yuvvexy is an important milestone for
TherapeuticsMD as we pursue our goal to provide women with novel
healthcare solutions that address their needs throughout life,” said
TherapeuticsMD CEO Robert G. Finizio. “If approved, Yuvvexy has the
potential to be a highly differentiated treatment option for the 32
million postmenopausal women in the United States who suffer from
symptoms of VVA. Yuvvexy is the first product candidate from our
pipeline of novel hormone therapies in development to address women’s
unmet health needs.”

The 505(b)(2) NDA submission for Yuvvexy is supported by the complete
Yuvvexy clinical program, including positive results of the phase 3
Rejoice Trial, which evaluated the effect of three doses of Yuvvexy (4
mcg, 10 mcg and 25 mcg) compared to placebo from baseline to week 12.
The results demonstrated statistically significant and clinically
meaningful improvements in dyspareunia, a co-primary endpoint, and
vaginal dryness, a secondary endpoint. Statistically significant results
were seen as early as two weeks of treatment. The NDA includes all three
doses of Yuvvexy that were evaluated in the Rejoice Trial.

About Yuvvexy

Yuvvexy is an applicator-free vaginal estradiol softgel capsule in
development 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 Vulvar and Vaginal Atrophy (VVA)

An estimated 32 million women in the United States are currently
suffering from symptoms of VVA, and only 2.3 million (7 percent) are
currently being treated with prescription therapy. VVA symptoms can
range from mild to severe and include dyspareunia, vaginal dryness,
urinary tract infections, and vaginal bleeding associated with sexual
activity. Vaginal dryness and dyspareunia are considered the most
bothersome symptoms of VVA. Because of the chronic nature of VVA due to
menopause, its symptoms will not likely resolve without intervention.

The burden of VVA in the United States may increase due to aging of the
population. Furthermore, due to increasing longevity, women may now
suffer from VVA or other conditions related to decreased reproductive
hormone levels for over one-third of their lives.

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 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 manufactures and distributes branded and generic
prescription prenatal vitamins as well as over-the-counter vitamins
under the vitaMedMD® and BocaGreenMD® brands. More
information is available at the following websites:,

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 approve the company’s new drug application for its TX-004HR
product candidate and whether any such approval will occur by the PDUFA
date; 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, Investor Relations