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 17β-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.
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 17β-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 17β-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 17β-estradiol and 50 mg natural progesterone could prove to be the lowest available dose of both hormones administered orally," Dr. Mirkin said.