BOCA RATON, Fla. -- (BUSINESS WIRE) -- TherapeuticsMD, Inc. (NYSE MKT: TXMD) announced today that it received the first-place prize for its poster at the The North American Menopause Society (NAMS) 2013 Annual Meeting recently held in Dallas. The poster detailed findings on the first investigational combination 17β-estradiol and progesterone capsule that may have overcome the well-recognized difficulties of achieving good bioavailability with oral administration of these hormones in combination. TherapeuticsMD is developing this compound, TX 12-001-HR, for FDA review.
Bioavailability of TX 12-001-HR, a capsule containing both 17β-estradiol and progesterone for oral use, was found to be similar to that of the standard reference products for the human hormones estradiol (Estrace®) and progesterone (Prometrium®), when taken concurrently. The poster, which was presented by James H. Pickar, M.D., Adjunct Associate Professor of Obstetrics and Gynecology, Columbia University College of Physicians & Surgeons in New York, described findings from a phase 1 study.
"NAMS congratulates TherapeuticsMD on its poster design award. Its poster was selected by an independent poster review committee. NAMS is pleased that so many outstanding research posters on women’s health and menopause were presented at our annual meeting," said Dr. Margery Gass, executive director of The North American Menopause Society.
Posters were evaluated on the basis of five criteria: appropriateness of study design, whether the conclusion flows from the results, overall quality of the science, impact of the study on the field of menopause, and visual appeal of the poster. Each category was rated on a 1-to-5 scale, with 1 = poor, 2 = fair, 3 = satisfactory, 4 = good, and 5 = excellent. The total score for each poster was the sum of the scores given for each of the criteria. Each poster was judged by three experts. The 113 poster presentations evaluated by a judging panel of 23 medical experts were eligible for up to four prizes, with first- and second-place winners receiving cash awards. TherapeuticsMD donated its first-place prize of $1,000 to NAMS.
"We are very pleased by this recognition among so many top-quality submissions. It is a testament to the dedication of our research team and a reflection of our commitment to develop innovative hormone therapies that fill the critical need for better treatments in the hormone and women’s health market. Using our technology to enable the delivery of body-identical hormones through a variety of dosage forms and administration routes, we hope to reverse what we believe has been a long-standing innovation gap in women’s health," said Robert Finizio, Co-Founder and Chief Executive Officer of TherapeuticsMD.
About the Study
The study, which was sponsored by TherapeuticsMD, Inc., was designed to determine the pharmacokinetics and bioavailability of its combination capsule of 17β-estradiol and progesterone (test drug: TX 12-001-HR). Participants included 66 healthy, postmenopausal women, age 40-65 years. Each participant was randomly assigned to begin one of three dosing sequences, each including three periods. During one period participants received a single dose of the test drug, and during two periods they received single doses of both the estradiol and progesterone reference drugs, which were taken concurrently. Blood samples were collected at multiple intervals, beginning one hour prior to start of dosing and continuing to 48 hours after dosing. Bioavailability was determined by measuring the rate and extent of absorption of the drugs.
About Hormone Therapy
Menopausal hormone therapy (HT) is the administration of hormones to treat menopausal symptoms resulting from a lack of naturally occurring hormones. Current HT options include FDA-approved combination products, FDA-approved estrogen-only and progestogen-only products, and non-FDA approved compounded bioidentical products. A body-identical combination product, which exactly matches the molecular structure of the human hormones estradiol and progesterone, is being developed by TherapeuticsMD and is currently in phase 3 clinical trials. 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 TX 12-001HR
TX 12-001-HR is a body-identical investigational drug designed to treat menopausal symptoms by replacing the 17ß-estradiol and progesterone hormones the body has stopped producing as the result of menopause. Enrollment is currently under way in the REPLENISH Trial, a phase 3, investigational research study made up of 1,550 patients to evaluate the safety and efficacy of TX 12-001-HR in reducing the symptoms of menopause. For more information, please visit: www.ReplenishTrial.com.
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is a women’s healthcare company focused on developing and commercializing products targeted exclusively for women. 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. Additionally, our business includes the manufacture and distribution of branded and generic prescription prenatal vitamins, as well as over-the-counter vitamins and cosmetics, under our vitaMedMD® and BocaGreenMD™ brands.
vitaMedMD® and TherapeuticsMD® are registered trademarks of TherapeuticsMD, Inc. BocaGreenMD™ is a trademark of TherapeuticsMD, Inc.
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding the continuation and ultimate results of clinical development of the Company’s proposed combination17β-estradiol and progesterone drug, the Company’s commitment to develop innovative hormone therapies to fill a critical need in the hormone and women’s health market, the Company’s intention and the means used to reverse what it believes is a long-standing innovation gap in women’s health, the use of hormone therapy to alleviate the symptoms of menopause and to reduce the health risks resulting from hormone deficiencies associated with menopause, the anticipated achievements, attributes, and benefits of TX 12-001HR, what the TX 12-001HR clinical trial is designed to measure, and the potential size of the market for pharmacy-compounded, bioidentical products 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; 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, 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.