BOCA RATON, Fla.--(BUSINESS WIRE)--TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare company, presented detailed results from the pivotal phase 3 Rejoice Trial for its TX-004HR product candidate in two late-breaking posters at the Endocrine Society’s 98th Annual Meeting and Expo, being held April 1-4, 2016, in Boston. 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 VVA due to menopause. Abstracts for the two posters, “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)” and “TX-004HR Vaginal Estradiol Effectively Treats Vulvar and Vaginal Atrophy (VVA) with Negligible to Low Systemic Absorption” have been published online by the Endocrine Society. VVA is a chronic and progressive condition that affects nearly half of postmenopausal women in the United States.
Detailed results from the Rejoice Trial, a randomized, double-blind, placebo-controlled, multicenter, phase 3 study of TX-004HR at 25 mcg, 10 mcg and 4 mcg doses in postmenopausal women with a moderate-to-severe dyspareunia, showed that at week 12, all TX-004HR doses compared with placebo significantly improved the four co-primary endpoints, including vaginal superficial cells, vaginal parabasal cells, vaginal pH, and the severity of dyspareunia (all p<0.00001 except dyspareunia at 4 mcg p=0.0149). Moreover, the changes in cytology, pH, and dyspareunia were significant at all intermediate time points (weeks 2, 6, and 8). The Rejoice Trial secondary endpoint result for vaginal dryness was also statistically significant for all three doses evaluated, as moderate-to-severe vaginal dryness was reported by 93% of patients at baseline, and was significantly improved (p<0.02) for all doses at weeks 2, 6, 8, and 12 (except the 4 mcg dose at week 2). A post-study patient questionnaire showed TX-004HR had high patient acceptability and satisfaction. TX-004HR was well tolerated; the most frequently reported treatment-emergent adverse events (AEs) were headache, vaginal discharge, nasopharyngitis and vulvovaginal pruritus. Vaginal discharge and vulvovaginal pruritus were numerically higher in the placebo group. No clinically significant differences in AEs between treatment and placebo groups were observed.
“The Rejoice Trial data demonstrated clinically meaningful improvements for postmenopausal women suffering from symptoms of VVA,” said TherapeuticsMD Chief Clinical Officer Brian Bernick, M.D., “With these positive data for both dyspareunia and vaginal dryness, which achieved statistical significance as early as two weeks with high user satisfaction rates, we strongly believe in TX-004HR as a promising potential treatment option for the millions of postmenopausal women suffering with VVA.”
The results from the pharmacokinetics (PK) sub-study of TX-004HR were also presented at ENDO 2016. The three doses of TX-004HR showed negligible to very low systemic absorption of estradiol. Safety parameters further revealed no significant differences in estrogen sensitivity tests and no signals of estrogenic stimulation of the endometrium.
“The Rejoice Trial data demonstrated that despite the low systemic absorption of estradiol, all doses of TX-004HR improved dyspareunia and dryness due to VVA, which I consider to be an excellent profile for a local estradiol treatment,” said Dr. David F. Archer, lead author of the PK substudy and Professor of Obstetrics and Gynecology at Eastern Virginia Medical School (EVMS) in Norfolk, VA.
TherapeuticsMD plans to use the Rejoice Trial data as the basis for a New Drug Application to the Food and Drug Administration (FDA) for TX-004HR. The company has also received conditional approval from the FDA for the brand name Yuvvexy™ for TX-004HR.
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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