TherapeuticsMD, Inc. (NYSE MKT: TXMD), a women’s healthcare company ("TherapeuticsMD" or the "Company"), announced today that it received approval to begin screening and enrolling subjects at its fiftieth site, the University of Florida College of Medicine, in the Company’s REPLENISH Trial, a phase 3, double-blind, placebo-controlled clinical trial designed to measure the safety and effectiveness of TX 12-001HR, the Company’s bio-identical combination 17ß-estradiol and progesterone drug candidate, in treating the symptoms of menopause.
Robert G. Finizio, Chief Executive Officer and Co-founder, said, “I am pleased to announce that we have achieved the fiftieth site enrollment for this promising drug candidate within our target timeline of a little more than three months from the start of patient enrollment in the REPLENISH Trial. This is an important milestone for us in that we set out to accomplish this goal before year-end, and we have in fact done so. I applaud the hard work and perseverance that brought about this significant achievement and look forward to making continued headway to support our goal of bringing innovative women’s healthcare products to market.”
About Hormone Therapy
Hormone 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. In a recent study commissioned by the Company, inThought™, a Symphony Health Solutions company, estimated the current market to be over $3.7 billion per year.
Clinical endpoints of the REPLENISH Trial (
) include measuring the reduction in frequency and severity of hot flashes over a 90-day period while ensuring endometrial protection for one year, in accordance with FDA Guidance for Estrogen/Progestins.
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is a women’s healthcare company focused on developing and commercializing products targeted exclusively for women. We are developing advanced hormone therapy pharmaceutical products based on novel technologies that enable delivery of bioidentical hormones through a variety of dosage forms and administration routes. We also manufacture and distribute branded and generic prescription prenatal vitamins, as well as over-the-counter vitamins and cosmetics, under our vitaMedMD
brands. More information is available at the following websites:
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding the Company’s expectations with respect to the
enrollment at the fiftieth site of the Company’s REPLENISH Trial, the design of the REPLENISH Trial, the Company’s belief that TX 12-001HR is a promising drug candidate and that the approval of the fiftieth site in the REPLENISH Trial is an important milestone, and the size and projected growth of the HT market
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.