By a News Reporter-Staff News Editor at Biotech Week -- TherapeuticsMD, Inc. (NYSE MKT: TXMD), a women's healthcare company ("TherapeuticsMD" or the "Company"), will detail the design of its REPLENISH Trial, a large-scale pivotal phase 3 clinical trial to evaluate TX-001HR, the first oral combination for FDA approval of 17b-estradiol and progesterone in a single capsule for the treatment of menopausal symptoms, at the session on May 2 of the International Menopause Society's 14th World Congress (see also TherapeuticsMD, Inc.).
The investigational combination product being studied in the phase 3 REPLENISH Trial uses SYMBODA™, an advanced technology developed and patented by the Company for solubilizing bio-identical hormones estradiol and progesterone.
TherapeuticsMD will present the study plan for its proprietary formulation at this year's gathering of the International Menopause Society, the leading global, nonprofit association dedicated to promoting women's health education and research.
"The combination of the bio-identical hormones 17b-estradiol and natural progesterone in a single oral dose represents a novel alternative for treating menopausal vasomotor symptoms in women with a uterus," said Sebastian Mirkin, M.D., Chief Medical Officer of TherapeuticsMD, who will present the study design for TX-001HR, the Company's investigational combination drug candidate.
Hormone therapy (HT) combining estrogen with a progestogen is considered to be the most consistently effective treatment for menopause symptoms for non-hysterectomized women. Currently there is no single FDA-approved product combining these two natural hormones. While compounding pharmacies produce unapproved combinations, the variable purity and potency have led many medical societies to choose not to recommend them. TX-001HR is an oral agent that, if approved, will be the first FDA approval of an oral combination of 17b-estradiol and progesterone in a gelatin capsule, representing a significant advancement in treatment options.
"We are encouraged by the potential of our SYMBODA technology to deliver an exciting first for HT dosing. If approved, our lowest combination dose containing 0.25 mg 17b-estradiol and 50 mg natural progesterone could prove to be the lowest available dose of both hormones administered orally," Dr. Mirkin said. About The REPLENISH Trial The phase 3 REPLENISH Trial is a prospective, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial evaluating the safety and efficacy of TX-001HR, a gelatin capsule containing both 17b-estradiol and progesterone for oral use being developed for FDA review by TherapeuticsMD. A total of 1,750 healthy postmenopausal women (age 40 to 65 years old) will be enrolled and randomly assigned to 1 of 4 oral doses of TX-001HR or placebo for a treatment period of 12 months.
The primary efficacy endpoint is mean change from baseline in the frequency and severity of moderate to severe vasomotor symptoms at weeks 4 and 12. The primary safety endpoint is rate of endometrial hyperplasia at 12 months, as determined by endometrial biopsy. About Hormone Therapy (also referred to as Hormone Replacement Therapy) Menopausal HT is the administration of hormones to treat menopausal symptoms which result from a lack of naturally occurring hormones. Current HT options include FDA-approved combination products using non-bio-identical hormones, FDA-approved estrogen-only and progestogen-only products, and non-FDA approved compounded bio-identical products. The market for pharmacy-compounded, bio-identical HT products is estimated to be approximately $1.5 billion per year. About TX-001HR TX-001HR is a proprietary solubilized bio-identical investigational drug designed to treat menopausal symptoms. Combining 17b-estradiol and natural progesterone in a single oral capsule, it is the first combination bio-identical hormone therapy being developed under FDA guidance to replace the hormones the body has stopped producing in menopause. TX-001HR uses hormones that are chemically and biologically identical to the estradiol and progesterone naturally produced in a woman's body. About SYMBODA Technology SYMBODA is a proprietary technology that solubilizes active pharmaceutical ingredients to create bio-identical hormone formulations that meet FDA uniformity and stability requirements. This technology is designed to deliver these hormones in new combinations, routes of administration, and lower dosages. About TherapeuticsMD, Inc.TherapeuticsMD, Inc. is a women's health care 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 bio-identical 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® and BocaGreenMD® brands.
Keywords for this news article include: Pharmaceuticals, Hormones, Technology, FDA Actions, Regulatory Agencies, TherapeuticsMD Inc., Clinical Trials and Studies.
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