TherapeuticsMD, Inc. (NYSE MKT: TXMD) announced today that it has initiated a Phase I study of its TX- 12-004-HR estradiol VagiCap™ for vulvar and vaginal atrophy (“VVA”). Already this study has enrolled 44% of the planned 50-patient cohort.
Robert G. Finizio, Co-Founder and Chief Executive Officer, said, “We believe this is a promising drug candidate based on our unique VagiCap delivery technology. Last year, estrogen sales for VVA were over $800 million and the category is growing rapidly, making this a particularly attractive opportunity for TherapeuticsMD. We are pleased with the rapid rate of enrollment in this study and look forward to reporting results.”
The Phase I study is designed to show pharmacokinetics levels and measure the effect of TX- 12-004-HR on certain clinical endpoints, including pH levels, vaginal cytology, and vulvar and vaginal pain and itching, which is the most bothersome symptom of VVA.
About Hormone TherapyHormone therapy (HT) is the administration of hormones to supplement a lack of naturally occurring hormones. HT options include natural, bioidentical, and non-bioidentical (conjugated) hormones. HT is projected to be the largest growth segment in the overall women’s health market. The potential market for pharmacy-compounded, bioidentical HT products is estimated to be approximately $1.5 billion per year. About TherapeuticsMD, Inc. TherapeuticsMD, Inc. is a women’s healthcare company focused on developing and commercializing products targeted exclusively for women. We manufacture and distribute branded and generic prescription prenatal vitamins, as well as over-the-counter vitamins and cosmetics, under our vitaMedMD ® and BocaGreenMD™ brands. We are currently developing advanced hormone therapy pharmaceutical products designed to alleviate the symptoms of and reduce the health risks resulting from menopause-related hormone deficiencies. We are also evaluating various other potential indications for our hormone technology, including oral contraception, preterm birth, vulvar and vaginal atrophy, and premature ovarian failure. More information is available at the following websites: www.therapeuticsmd.com, www.vitamedmd.com, www.vitamedmdrx.com, and www.bocagreenmd.com. vitaMedMD ® is a registered trademark and TherapeuticsMD™ and BocaGreenMD™ are trademarks of TherapeuticsMD, Inc. Except for the historical information contained herein, the matters set forth in this press release, including statements regarding the Company’s belief that its TX-12-004 estradiol VagiCap is a promising drug candidate based on the Company’s delivery technology, that it is now positioned to move three product candidates into late-stage clinical trials, the Company’s expectations with respect to the timing of its clinical trials, and the status of the pharmacokinetic studies with TX 12-004HR are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including but not limited to: timely and successful completion of clinical studies and the results thereof; challenges and costs inherent in product marketing; the risks and uncertainties associated with economic and market conditions; risks and uncertainties associated with the Company’s business and finances in general; and other risks detailed in the Company’s filings with the U.S. Securities and Exchange Commission including its annual report on Form 10-K filed on March 12, 2013, reports on Form 10-Q and Form 8-K, and other such filings. These forward-looking statements are based on current information that may change. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and the Company undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.