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.
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