BOCA RATON, Fla.--(BUSINESS WIRE)--TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare company, today announced the publication of two manuscripts detailing results of the company’s phase 3 Rejoice Trial in Menopause: The Journal of The North American Menopause Society, a widely-regarded forum for scholarly articles on the leading research related to menopause. The Rejoice Trial is the pivotal phase 3 study of TX-004HR, an investigational bio-identical 17β-estradiol vaginal softgel capsule, for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar vaginal atrophy (VVA) in postmenopausal women.
The manuscripts review the positive results of TX-004HR across all pre-specified primary and secondary endpoints in the Rejoice Trial, as well as data from a pharmacokinetic (PK) substudy demonstrating the low systemic absorption of TX-004HR. Both manuscripts are available online in the journal Menopause, as well as in the “Investors & Media” section of the company’s website, www.therapeuticsmd.com.
“Publication of our two manuscripts on the Rejoice Trial is an important achievement for our company, reflecting the clinical rigor that guides development of our unique pipeline of hormone therapies designed to address women’s healthcare needs,” said TherapeuticsMD CEO Robert G. Finizio. “If approved, TX-004HR has the potential to be a highly differentiated treatment option for postmenopausal women in the United States who suffer from moderate-to-severe dyspareunia, a symptom of VVA. We look forward to the Food and Drug Administration completing its review of the TX-004HR New Drug Application (NDA), and to the potential launch of TX-004HR in 2017.”
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 7, 2017 to complete its review of the company’s 505(b)(2) NDA submission for TX-004HR. The NDA is supported by the complete TX-004HR clinical program, including positive results of the phase 3 Rejoice Trial, which evaluated the effect of three doses of TX-004HR (4 mcg, 10 mcg and 25 mcg) compared to placebo from baseline to week 12.
The first manuscript, titled “The REJOICE trial: a phase 3 randomized, controlled trial evaluating the safety and efficacy of a novel vaginal estradiol soft-gel capsule for symptomatic vulvar and vaginal atrophy,” reviews the results of the Rejoice Trial, which demonstrated statistically significant improvements in dyspareunia, based on four co-primary endpoints, and vaginal dryness, a secondary endpoint, across all three doses of TX-004HR compared to placebo. The manuscript also reviews the safety and tolerability of TX-004HR. TX-004HR had a favorable safety profile and was well-tolerated. No clinically significant differences in adverse events were observed between treatment and placebo groups.
The second manuscript, titled “TX-004HR vaginal estradiol has negligible to very low systemic absorption of estradiol,” reviews the results of the PK substudy of the Rejoice Trial, which demonstrated that all three doses of TX-004HR showed negligible to very low systemic absorption of estradiol. Safety parameters further revealed no significant differences in estrogen sensitive tests and no signals of estrogenic stimulation of the endometrium.
“We are very encouraged by the safety and efficacy profile of TX-004HR and, if approved, believe this product candidate could become a potential best in class therapy for postmenopausal women seeking to effectively manage dyspareunia, a symptom of VVA,” said TherapeuticsMD Chief Clinical Officer Brian Bernick, M.D.
About Vulvar and Vaginal Atrophy (VVA)
An estimated 32 million women in the United States are currently suffering from symptoms of VVA, and only 2.3 million (7 percent) are currently being treated with prescription therapy. VVA symptoms can range from mild to severe and include dyspareunia, vaginal dryness, urinary tract infections, and vaginal bleeding associated with sexual activity. Vaginal dryness and dyspareunia are considered the most bothersome symptoms of VVA. Because of the chronic nature of VVA due to menopause, its symptoms will not likely resolve without intervention. The burden of VVA in the United States may increase due to aging of the population. Furthermore, due to increasing longevity, women may now suffer from VVA or other conditions related to decreased reproductive hormone levels for over one-third of their lives.
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 late stage clinical pipeline includes two phase 3 product candidates: TX-001HR for treatment of moderate-to-severe vasomotor symptoms (VMS) due to menopause and TX-004HR for treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause. The company also manufactures and distributes branded and generic prescription prenatal vitamins as well as over-the-counter prenatal vitamins under the vitaMedMD® and BocaGreenMD® brands.
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 company will be able to prepare a new drug application for its TX-001HR product candidate and, if prepared, whether the FDA will accept and approve the application; whether the FDA will approve the company’s new drug application for its TX-004HR product candidate and whether any such approval will occur by the PDUFA date; 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.