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TherapeuticsMD Presents Poster at ACOG 2016 with Additional Secondary Endpoint Data from Phase 3...

Saturday, May 14, 2016   (0 Comments)
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TherapeuticsMD Presents Poster at ACOG 2016 with Additional Secondary Endpoint Data from Phase 3 Rejoice Trial

Data Show Improvement in Female Sexual Function Index with TX-004HR

BOCA RATON, Fla.--(BUSINESS WIRE)--TherapeuticsMD, Inc. (NYSE MKT:TXMD), an innovative women’s healthcare company, presented additional secondary endpoint results from the pivotal phase 3 Rejoice Trial for its TX-004HR product candidate at the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting held May 14-17, 2016, in Washington, DC.

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

Data presented in the poster assess the effect of Yuvvexy on female sexual dysfunction in postmenopausal women using the Female Sexual Function Index (FSFI). The FSFI is a validated, self-reporting questionnaire consisting of 19 questions designed to assess the domains of arousal, desire, satisfaction, orgasm, lubrication, and pain. After 12 weeks, total FSFI scores increased with all three doses of Yuvvexy (4 mcg, 10 mcg, and 25 mcg) and placebo, with a statistically significant difference at the 10 mcg and 25 mcg doses versus placebo. The poster, entitled “Improvement in Postmenopausal Sexual Function with TX-004HR as Measured by FSFI,” may be viewed in the “Investors and Media” section of the company’s website under Events and Presentations.

“We are pleased to present these additional findings from the Rejoice Trial at ACOG as we prepare to file a New Drug Application (NDA) for Yuvvexy as a treatment for dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause,” said TherapeuticsMD co-founder and Chief Clinical Officer Brian Bernick, M.D. “The FSFI data reflect the breadth and depth of our positive phase 3 Rejoice Trial and suggest that Yuvvexy has the potential to be a highly differentiated new therapy for menopausal women, if approved.”

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; 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
or
Media:
WCG
Elliot Fox, 212-257-6724
Director, Media & Engagement
efox@w2ogroup.com


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BioFlorida, Inc. | 901 NW 35th Street | Boca Raton, FL 33431
(P) 561-653-3839 (F) 561-653-3840 admin@bioflorida.com
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