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TherapeuticsMD starts enrollment in phase III study of TX 12-001-HR to treat symptoms of menopause

Boca Raton, FloridaTuesday, September 10, 2013, 17:30 Hrs  [IST]

TherapeuticsMD, Inc., a women’s healthcare company focused on developing and commercializing products targeted exclusively for women, has announced the enrollment and dosing of the first patient in the REPLENISH Trial, a phase III clinical trial designed to measure the safety and effectiveness of TX 12-001-HR, its bioidentical combination 17ß-estradiol and progesterone drug candidate, in treating the symptoms of menopause.

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.

Robert G Finizio, co-founder and chief executive officer, said, “We are pleased to enroll our first patient in the pivotal phase III clinical trial of TX 12-001-HR. We believe this novel combination of 17ß-estradiol and progesterone may provide a safer and effective alternative as compared to current hormone therapies, and we look forward to achieving full enrollment of patients in the trial for this promising drug candidate.”

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. The potential market for pharmacy-compounded, bioidentical HT products is estimated to be approximately $1.5 billion per year.

TX 12-001-HR is an investigational drug designed to replace the 17ß-estradiol and progesterone hormones the body has stopped producing as the result of menopause, and to reduce the symptoms of menopause due to the reduction of those hormones. Enrollment is currently underway in the REPLENISH Trial, a phase III clinical study made up of 1,550 patients to evaluate the safety and efficacy of TX 12-001-HR in reducing the symptoms of menopause.


TherapeuticsMD, Inc. is a women’s healthcare company focused on developing and commercializing products targeted exclusively for women.

 
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