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Daré Bioscience Announces FDA Clearance of Investigational New Drug (IND) Application for DARE-VVA1, a Novel Intravaginal Formulation of Tamoxifen for Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy Associated with Menopause
DARE-VVA1 has the potential to be the first therapeutic non-hormonal vaginal option for the treatment of moderate to severe dyspareunia, a symptom of vulvar
About this update from Dare Bioscience, Inc.
[{"type":"text","content":"DARE-VVA1 has the potential to be the first therapeutic non-hormonal vaginal option for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy (VVA) in women who cannot or should not take supplemental estrogen\nSAN DIEGO, Dec. 07, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health innovation, today 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, Daré can begin planning for an anticipated Phase 2 randomized, double-blinded, placebo-controlled, dose-finding clinical study of DARE-VVA1. VVA is an inflammation and thinning of the vaginal epithelium due to chronic hypo-estrogenism, which is the reduction in levels of circulating estrogen. Typical symptoms include vaginal dryness, itching, burning, and painful intercourse (dyspareunia), adversely impacting quality of life. VVA most commonly occurs in postmenopausal women, in whom the prevalence is over 50% but survey data indicate only 56% of women experiencing menopausal vaginal changes discuss these symptoms with healthcare professionals, highlighting that the syndrome is often underdiagnosed. Products containing estrogen are commonly used to treat VVA but some women cannot or choose not to use these products, including those with a history of hormone-receptor positive (HR+) breast cancer. “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 Daré 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 Daré 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.” About DARE-VVA1 DARE-VVA1 is an investigational, proprietary formula...