FDA approves clindamycin phosphate gel for treatment of bacterial vaginosis

The US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) clindamycin phosphate vaginal gel, 2% (Xaciato; Daré Bioscience), formerly known as DARE-BV, for the treatment of bacterial vaginosis in females 12 years and older.

Bacterial vaginosis affects an estimated 21 million women in the US and the most common cause of vaginitis in the world, Daré Bioscience stated in a press release.¹

“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. San Diego, California. “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. 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.”

The approval of the NDA is backed by positive data from the DARE-BVFREE phase 3, randomized, multi-center, double-blinded, placebo-controlled clinical trial (NCT04370548) examining Xaciato as a treatment for bacterial vaginosis in women, according to a company press release.

“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, PhD, chief scientific officer, Daré Bioscience. “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.”

Reference:

1. Daré announces fda approval of xaciato™ (Clindamycin phosphate) vaginal gel as a treatment for bacterial vaginosis | daré bioscience. Accessed December 8, 2021. https://ir.darebioscience.com/news-releases/news-release-details/dare-announces-fda-approval-xaciatotm-clindamycin-phosphate