Dare Bioscience Inc. (NASDAQ: DARE) has announced that the FDA has approved XACIATO (clindamycin phosphate vaginal gel, 2%), which was formerly called DARE-BV1, for treating bacterial vaginosis in females above 12 years.
FDA approves XACIATO
CEO Dare Bioscience Sabrina Martucci Johnson said, “The FDA approval of XACIATO marks a major milestone not only for Daré as a company but, importantly, for the 21 million women impacted by bacterial vaginosis. It is our goal as a company to accelerate the development of differentiated products that can improve outcomes and convenience for women. In the case of XACIATO, this FDA approval comes just three years after we licensed this technology. We are grateful to the FDA for their thoughtful review and the alignment on labeling that gives healthcare providers clear insights into how to use XACIATO in those patient populations in greatest need of a therapeutic option, such as pregnant women and women with recurrent episodes of bacterial vaginosis.”
The company hopes that the approval is the first of the many the company expects in its efforts to improve women’s lives with treatment alternatives that address persistent unmet needs.
Vaginosis is an overgrowth of bacteria found in Vagina
David Friend, the company’s Chief Scientific Officer, said, “Bacterial vaginosis is not a sexually transmitted infection, but rather an overgrowth of bacteria naturally found in the vagina, which upsets the balance of the natural vaginal microbiome and leads to not only distressing symptoms of odor and discharge, but also increases a woman’s risk of preterm birth, infertility, and infections. Today, approximately half of the women treated for bacterial vaginosis experience a recurrence within 12 months of treatment. There is a need for more efficacious and convenient treatment options, particularly products with improved clinical outcomes for not only the newly diagnosed women, but, importantly, also for the women who experience multiple episodes of bacterial vaginosis each year.”
“Now that we have achieved this important demonstration of this drug delivery hydrogel platform technology, we are actively exploring the opportunity to leverage it across other unmet needs in women’s health,” added Friend.
