FDA approves gel for bacterial vaginosis
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Daré Bioscience announced the FDA approval of Xaciato, a vaginal gel, for the treatment of bacterial vaginosis in females aged 12 years or older.
Xaciato (clindamycin phosphate vaginal gel, 2%) was formerly known as DARE-BVI.
According to Daré, bacterial vaginosis is the most common cause of vaginitis globally and is estimated to affect approximately 21 million women in the United States. The prevalence is higher among Black (51%) and Hispanic (32%) women compared with white women (23%).
“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,” Daré President and CEO Sabrina Martucci Johnson, MS, said in a press release.
It is estimated that up to 50% of women treated for bacterial vaginosis will experience a recurrence within a year 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,” Daré Chief Scientific Officer David Friend, PhD, said in the release.
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Dare Bio. Dare announces FDA approval of Xaciato vaginal gel as a treatment for bacterial vaginosis. https://ir.darebioscience.com/news-releases/news-release-details/dare-announces-fda-approval-xaciatotm-clindamycin-phosphate. Accessed Dec. 8, 2021.
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