TherapeuticsMD Announces Multiple Presentations Related to Yuvvexy™ (TX-004HR) at Two Upcoming Medical Conferences

Nine presentations at annual meetings of the International
Menopause Society and North American Menopause Society

New data to be presented from Women’s EMPOWER Survey on
perceptions of VVA

BOCA RATON, Fla.–(BUSINESS WIRE)–TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare
company, today announced the schedule of nine posters and oral
presentations at upcoming medical conferences related to Yuvvexy, the
conditionally-approved trade name for TX-004HR, an investigational
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.

The presentations support the results from the Yuvvexy clinical
development program and further identify women’s perceptions of VVA and
current available treatment options. Additional data to be presented
provide new insights about the lack of understanding of VVA as a serious
medical condition. The posters and presentations will be made at annual
meetings of the International Menopause Society (IMS) on September 28 –
October 1 in Prague, Czech Republic, and the North American Menopause
Society (NAMS) on October 5-8 in Orlando, Florida.

“These presentations reflect the breadth and depth of our Yuvvexy
clinical program, including the previously-presented phase 3 Rejoice
Trial data, as well as the need for improved understanding of VVA as a
serious medical condition, its symptoms such as dyspareunia, and the
available treatment options,” said TherapeuticsMD co-founder and Chief
Clinical Officer Brian Bernick, M.D. “We look forward to our IMS and
NAMS presentations regarding Yuvvexy and, if approved, establishing this
innovative product as a highly differentiated new therapy designed to
satisfy the unmet needs of menopausal women suffering from symptoms of
VVA.”

The posters and presentations will be made available on the Investors &
Media section of the company’s website at www.therapeuticsmd.com.
Details include:

 

IMS Oral Presentations

Title

    The REJOICE Trial: A Phase 3 Randomized Controlled Trial
Evaluating the Safety and Efficacy of a Novel Vaginal Estradiol
Softgel Capsule for Symptomatic Vulvar and Vaginal Atrophy (VVA)

Date/Time

   

Friday, September 30, 2:30 – 2:45 p.m. (Oral Presentation)

       
Title     TX-004HR Vaginal Estradiol Effectively Treats Vulvar and Vaginal
Atrophy (VVA) with Negligible to Low Systemic Absorption of Estradiol

Date/Time

   

Friday, September 30, 2:45 – 3:00 p.m. (Oral Presentation)

       
Title     Improvement in Postmenopausal Sexual Dysfunction with TX-004HR as
Measured by FSFI

Date/Time

   

Saturday, October 1, 10:15 – 10:30 a.m. (Oral Presentation)

 

NAMS Oral Presentations and Posters

Title     TX-004HR Improves Vaginal Physiology and Dyspareunia with
Negligible Systemic Absorption

Date/Time

   

Thursday, October 6, 4:30 – 4:45 p.m. (Oral Presentation)

       

Title

    Significant Improvement in Vaginal Epithelium with TX-004HR in
Postmenopausal Women with Moderate-to-Severe Dyspareunia Associated
with Vulvar and Vaginal Atrophy (VVA)

Date/Time

   

Thursday, October 6, 5:00 – 5:15 p.m. (Oral Presentation)

       

Title

    The Women’s EMPOWER Survey: Identifying Women’s Perceptions of
Vulvar and Vaginal Atrophy (VVA)

Date/Time

   

Thursday, October 6, 5:30 – 5:45 p.m. (Oral Presentation)

       

Title

    The Women’s EMPOWER Survey: Women’s Knowledge and Treatment of
Vulvar and Vaginal Atrophy (VVA) Remains Low, Years after Previous
Surveys

Date/Time

   

Thursday, October 6, 6:00 – 7:00 p.m. (Poster Presentation)

       

Title

    The Effect of Body Position on the Pharmacokinetics of TX-004HR,
Estradiol Vaginal Softgel Capsule

Date/Time

   

Thursday, October 6, 6:00 – 7:00 p.m. (Poster Presentation)

       
Title     TX-004HR Provides Robust Efficacy for Symptomatic Postmenopausal
Vulvar and Vaginal Atrophy (VVA) while Providing Negligible to Very
Low Systemic Absorption of Estradiol: Results of Phase 2 and Phase 3
Trials

Date/Time

   

Friday, October 7, 1:45-2:00 p.m. (Oral Presentation)

   

About TherapeuticsMD, Inc.

TherapeuticsMD, Inc. is an innovative healthcare company focused on
developing and commercializing products exclusively for women. With its
SYMBODA™ technology for the solubilization of bio-identical female
hormones, TherapeuticsMD is developing 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® brands. More information is available at the
following websites: www.therapeuticsmd.com,
www.vitamedmdrx.com
and www.bocagreenmd.com.

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:
www.therapeuticsmd.com/pressreleases.aspx.

Contacts

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