The U.S. Food and Drug Administration or FDA has accepted women's healthcare company TherapeuticsMD Inc.'s (TXMD) Investigational New Drug or IND application for TX12-004HR, a vaginal estradiol suppository. The company is developing TX12-004HR for vulvar and vaginal atrophy, a thinning of the vaginal walls that occurs as estrogen levels drop during menopause. The acceptance of the IND will allow the Company to begin clinical trials.
Julia Amadio, Chief Product Officer stated, "We are very excited to move forward with testing this simple, novel delivery of vaginal estradiol for vulvar and vaginal atrophic symptoms in postmenopausal women. We believe that there is a large and growing unmet need for this product as women will continue to develop vaginal atrophy after menopause without therapy."
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