TherapeuticsMD Reports Positive PK Trial Results For Estradiol Vaginal Capsule

(RTTNews) - TherapeuticsMD, Inc. (TXMD), a women's healthcare company, announced the final PK results from two studies of TX 12-004-HR, a rapidly acting vaginal preparation capsule versus Novo Nordisk's Vagifem.

ESTR-1K-499 was an open label, single dose crossover, relative bioavailability study comparing 10µg of TX 12-004-HR to 10µg of Vagifem. ESTR-1K-500 was the study with the same design, but compared 25µg of TX 12-004-HR to 25µg of Vagifem. The trial results demonstrated substantially lower systemic estradiol exposure of TX 12-004-HR when compared to Vagifem. In conjunction with the earlier reported efficacy of TX 12-004-HR, this PK data suggests that TX 12-004-HR may provide therapeutic advantages over Vagifem.

The side effects related to vaginal hormone therapy may be related to peak concentrations or overall exposure to the hormones. According to the company, the maximal concentration of TX 12-004-HR estradiol was nearly half that observed with Vagifem and the overall exposure to estradiol was around one-third that observed with Vagifem. The 24-hour exposure to estradiol in the case of 25µg dose of TX 12-004-HR was 3.3 fold lower than the same dose of Vagifem, and in the case of 10µg dose of TX 12-004-HR was 2.6 fold lower than the same dose of Vagifem.

The company said it aims to create a faster-acting, rapidly dissolving VagiCap with less systemic estradiol exposure in a more elegant form.

TX 12-004-HR estradiol VagiCap is an investigational drug matching the molecular structure of estradiol that is designed to treat moderate to severe VVA symptoms associated with menopause.