FDA Approves Vaginal Gel for Treatment of Bacterial Vaginosis

"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," said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. "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. We hope that this is the first of many FDA approvals in our efforts to improve the lives of women with treatment options that address some of the most persistent unmet needs."

"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," said David Friend, Ph.D., Daré's Chief Scientific Officer. "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."