Bacterial vaginosis (BV) is the most common type of vaginal infection in women of reproductive age. In the U.S. alone, an estimated 21 million women aged 14-49 years have BV. Current treatment often consists of oral antibiotics, but research has shown effective drug delivery is essential to optimizing drug therapy for BV.
DARE-BV1 is a thermosetting vaginal gel formulated with clindamycin phosphate 2% designed for prolonged, localized release of the antibiotic. In an investigator-initiated proof-of-principal study, an 86% clinical cure rate after one dose of DARE-BV1 was demonstrated (n=28).
A single Phase 3 clinical trial of DARE-BV1, if successful, is expected to support US FDA marketing approval.
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