Full Press Release Details
TherapeuticsMD, Inc. 8-K
TherapeuticsMD Announces New
Drug Application Submission for Yuvvexy (TX-004HR)
BOCA RATON, Fla., July 7, 2016
- 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 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 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: www.therapeuticsmd.com/pressreleases.aspx.
Director of Investor Relations