Dare Bioscience announces FDA clearance of IND application for DARE-VVA1

Dare Bioscience announced that the U.S. Food and Drug Administration, FDA, has cleared its investigational new drug, IND, application for DARE-VVA1, a novel intravaginal proprietary formulation of tamoxifen being developed as a non-hormonal treatment option for moderate to severe dyspareunia, a symptom of VVA associated with menopause. With the IND clearance from the FDA, Dare can begin planning for an anticipated Phase 2 randomized, double-blinded, placebo-controlled, dose-finding clinical study of DARE-VVA1. “Although localized estrogen therapy is effective in reducing the symptoms of VVA and is commonly prescribed, there remains a large unmet need for non-hormonal treatment options for symptoms of VVA for women who cannot or choose not to use estrogen-based products,” said Sabrina Martucci Johnson, President and CEO of Dare Bioscience. “While we do not plan to commence the Phase 2 study until after we secure additional capital, this IND clearance marks an important regulatory step for Dare that supports our strategic discussions as we advance our portfolio of innovative product candidates and strive to address some of women’s most persistent unmet needs.”