FDA Gives Nod To Daré Bioscience's Trial Of Non-Hormonal Treatment For Dyspareunia, Seeks Additional Funding

Daré Bioscience Inc DARE announced that the FDA has cleared its investigational new drug (IND) application for DARE-VVA1 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).

DARE-VVA1 is an investigational, proprietary formulation of tamoxifen for intravaginal administration.

"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," said Sabrina Martucci Johnson, President and CEO.

Price Action: DARE shares are down 3.74% at $0.33 on the last check Thursday.