DARE-BV1, a gel that treats bacterial vaginosis, was granted FDA approval on its Prescription Drug User Fee Act (PDUFA) date today.
DARE-BV1 (clindamycin phosphate) was approved today by the US 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 in the US.
Sabrina Martucci Johnson, president and CEO of Daré Bioscience, said, “It is our goal to bring to market a product that has the potential to improve outcomes and convenience for women, as DARE-BV1 demonstrated it has the potential to do in the phase 3 study, where a single vaginal dose of DARE-BV1 achieved clinical cure rates of 70-81%."
The approval comes after the FDA granted DARE-BV1 New Drug Application (NDA) Priority Review and set a Prescription Drug User Fee Act (PDUFA) date for today, December 7, 2021, to complete reviewing the drug. DARE-BV1 previously received Fast Track and Qualified Infectious Disease Product designations from the FDA.
The NDA was assigned in response to positive data was reported from the DARE-BVFREE phase 3 study, a randomized, double-blind, placebo-controlled clinical trial. Results from the DARE-BVFREE trial indicated one dose of DARE-BV1 improved clinical cure rates above previously approved products; other FDA-approved products have clinical cure rates ranging from 37-68%.
The study reached its primary endpoint, demonstrating statistically significant results of DARE-BV1 over placebo. At Day 7-14, the clinical cure rate was 81%, and decreased slightly to 77% at Day 21-30.
DARE-BV1 is a vaginal gel, a thermosetting bioadhesive hydrogel formulation of 2% clindamycin phosphate. DARE-BV1 treats bacterial vaginosis ins a single application, using body temperature to turn from a solution to a gel.
With this approval, Daré Bioscience is planning a market introduction of DARE-BV1 in 2022.