TherapeuticsMD Presents Phase 1 Data On 17ß-Estradiol And Progesterone Capsule

(RTTNews) - TherapeuticsMD Inc. (TXMD) announced that Pharmacokinetic study being presented tomorrow evening in a poster session at The North American Menopause Society 2013 Annual Meeting in Dallas suggests that the first combination 17ß-estradiol and progesterone capsule in clinical development may have overcome the well-recognized difficulties of achieving good bioavailability with oral administration of these hormones in combination.

According to the company, In a study of 66 healthy postmenopausal women, bioavailability of TX 12-001-HR, a capsule containing both 17ß-estradiol and progesterone for oral use being developed by the company, was found to be similar to that of the standard reference products for the human hormones estradiol (Estrace) and progesterone (Prometrium), when taken concurrently.

Hormone therapy is widely used to alleviate the symptoms of menopause and to reduce the health risks resulting from hormone deficiencies associated with menopause.

The company noted that in this study, bioequivalence criteria were met for all analytes, except Cmax for total estrone. The extent of absorption of the estradiol and progesterone in the Test capsule was similar to that for Estrace and Prometrium, while the rate of estradiol absorption for the Test capsule appeared to be slightly faster than for the Estrace reference.

The company said that 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.