TherapeuticsMD initiates Phase I vulvar and vaginal atrophy study
Aug 26, 2013 (MarketLine via COMTEX) --
TherapeuticsMD, Inc., a provider of women's healthcare products, has initiated a Phase I study of its TX- 12-004-HR estradiol VagiCap for vulvar and vaginal atrophy, or VVA.
Robert G. Finizio, Co-Founder and CEO, said, "We believe this is a promising drug candidate based on our unique VagiCap delivery technology. Last year, estrogen sales for VVA were over $800 million and the category is growing rapidly, making this a particularly attractive opportunity for TherapeuticsMD. We are pleased with the rapid rate of enrollment in this study and look forward to reporting results."
The Phase I study is designed to show pharmacokinetics levels and measure the effect of TX- 12-004-HR on certain clinical endpoints, including pH levels, vaginal cytology, and vulvar and vaginal pain and itching, which is the most bothersome symptom of VVA.
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