The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for DARE-BV1 for the treatment of bacterial vaginosis.
DARE-BV1 is an investigational thermosetting bioadhesive hydrogel containing clindamycin phosphate 2%. The product is designed as a one-time vaginally administered treatment.
The NDA is supported by data from the multicenter, randomized, double-blind, placebo-controlled phase 3 DARE-BVFREE study (ClinicalTrials.gov Identifier: NCT04370548), which evaluated the efficacy and safety of DARE-BV1 in 307 patients aged 12 years and older diagnosed with bacterial vaginosis. Patients were randomly assigned 2:1 to receive a single vaginal dose of DARE-BV1 or placebo.
Treatment with DARE-BV1 was found to be statistically superior to placebo at the test of cure visit at day 21-30 in the intent-to-treat population (primary endpoint), with 70% of patients clinically cured compared with 36% for placebo. Clinical cure was defined as resolution of abnormal vaginal discharge associated with bacterial vaginosis, clue cells less than 20% of total epithelial cells on microscopy, and a negative 10% KOH “whiff” test.
In the per protocol population (n=148), DARE-BV1 demonstrated clinical cure rates of 77% at day 21 to 30 and 81% at day 7 to 14 compared with 43% and 30% for placebo, respectively.
A Prescription Drug User Fee Act (PDUFA) target date of December 7, 2021 has been set for the application.
Daré Bioscience announces FDA acceptance and Priority Review of New Drug Application for DARE-BV1 for the treatment of bacterial vaginosis. News release. Daré Bioscience, Inc. Accessed August 9, 2021. https://www.globenewswire.com/news-release/2021/08/09/2277060/30757/en/Dar%C3%A9-Bioscience-Announces-FDA-Acceptance-and-Priority-Review-of-New-Drug-Application-for-DARE-BV1-for-the-Treatment-of-Bacterial-Vaginosis.html.