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TherapeuticsMD Presents Detailed Results from Phase 3 Rejoice Trial in Postmenopausal Women with Vulvar and Vaginal Atrophy (VVA) at ENDO 2016

TX-004HR Showed Statistically Significant Improvements in Dyspareunia (Vaginal Pain During Sexual Intercourse) and Vaginal Dryness at All Doses (25 mcg, 10 mcg and 4 mcg)

Pharmacokinetics Substudy Showed Negligible to Very Low Systemic Absorption of 17β-Estradiol

BOCA RATON, Fla.--(BUSINESS WIRE)--Apr. 2, 2016-- 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.

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.

Source: TherapeuticsMD, Inc.

TherapeuticsMD, Inc.
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