TherapeuticsMD Provides TX-004HR Regulatory Update

BOCA RATON, Fla.–(BUSINESS WIRE)–TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare
company, today announced that, on April 7, 2017, the Company received a
letter from the U.S. Food and Drug Administration (FDA) stating that, as
part of the FDA’s ongoing review of the Company’s new drug application
(NDA) for TX-004HR, the Company’s applicator-free vaginal estradiol
softgel drug candidate for the treatment of moderate to severe
dyspareunia (vaginal pain during sexual intercourse), a symptom of
vulvar and vaginal atrophy (VVA), in post-menopausal women, the FDA has
identified deficiencies that preclude discussion of labeling and
postmarketing requirements/commitments at this time. The letter states
that the notification does not reflect a final decision on the
information under review.

The letter does not specify the deficiencies identified by the FDA and
at this time the Company is not aware of the nature of the deficiencies.
The Company intends to work with the FDA to understand the nature of the
deficiencies and resolve them as quickly as possible.

The FDA previously set a target action date under the Prescription Drug
User Fee Act (PDUFA) of May 7, 2017 to complete the FDA’s review of the
NDA and had communicated to the Company the FDA’s target date of April
9, 2017 for communicating to the Company proposed labeling and/or
postmarketing requirements/commitments in accordance with FDA’s PDUFA
Reauthorization Performance Goals And Procedures – Fiscal Years 2013
Through 2017.

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 NDA for its TX-004HR product
candidate; 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 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; 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.

Contacts

TherapeuticsMD, Inc.
David DeLucia, 561-961-1900
Director,
Investor Relations
David.DeLucia@TherapeuticsMD.com