Specialty pharmaceutical company TherapeuticsMD has obtained investigational new drug (IND) application clearance from the US Food and Drug Administration (FDA) for vaginal estradiol suppository, TX12-004HR.
The IND acceptance will allow the company to advance the development of TX12-004HR for vulvar and vaginal atrophy (VVA) into clinical trials.
VVA is a thinning of the vaginal walls that happens because of the drop in estrogen levels during menopause.
TherapeuticsMD chief product officer Julia Amadio said the company is moving forward to test the 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," Amadio added.
