FDA approves DARE-BV1 to treat bacterial vaginosis
DARE-BV1 (clindamycin phosphate) was approved today by the United States Food and Drug Administration (FDA) to treat bacterial vaginosis.
DARE-BV1 was developed by Daré Bioscience, Inc., a clinical-stage biopharmaceutical company that develops and advances women’s health products.
Bacterial vaginosis is associated with serious health risks and very disruptive symptoms, and is estimated to affect 21 million people in the United States.
Sabrina Martucci Johnson, President and CEO of Daré Bioscience, said: “Our goal is to bring to market a product that has the potential to improve outcomes and convenience for women, as DARE-BV1 has demonstrated. that it has the potential to do so in phase 3, where a single vaginal dose of DARE-BV1 has achieved clinical cure rates of 70-81%. “
The approval comes after the FDA granted the Priority Review of the New Drug Application (NDA) DARE-BV1 and set a Prescription Drug User Fee Act (PDUFA) date for today. hui on December 7, 2021, to complete the review of the drug. DARE-BV1 has previously received Fast Track and Qualified Infectious Disease Product designations from the FDA.
The NDA was assigned in response to positive data reported from the Phase 3 DARE-BVFREE study, a randomized, double-blind, placebo-controlled clinical trial. Results from the DARE-BVFREE trial indicated that one dose of DARE-BV1 improved clinical cure rates compared to previously approved products; other products approved by the FDA have clinical cure rates ranging from 37 to 68%.
The study met its primary endpoint, demonstrating statistically significant results of DARE-BV1 compared to placebo. On days 7-14, the clinical cure rate was 81% and decreased slightly to 77% on days 21-30.
DARE-BV1 is a vaginal gel, a 2% clindamycin phosphate thermosetting bioadhesive hydrogel formulation. DARE-BV1 treats bacterial vaginosis in a single application, using body temperature to change from solution to gel.
With this approval, Daré Bioscience expects DARE-BV1 to be marketed in 2022.