Posted by Michael Wonder on 11 Mar 2020
Daré Bioscience receives FDA fast track designation for DARE-BV1 for the treatment of bacterial vaginosis
10 March 2020 - DARE-BV1 demonstrated an 86% clinical cure rate in evaluable subjects at the test-of-cure visit after a single administration in an investigator-initiated proof of concept study, which is higher than the clinical cure rates of current FDA-approved products.
Daré Bioscience today announced that the U.S. FDA has granted fast track designation for DARE-BV1 for the treatment of bacterial vaginosis (BV) in women.
DARE-BV1 was previously granted qualified infectious disease product designation for the treatment of BV in August 2019. DARE-BV1 is a novel thermosetting bioadhesive hydrogel containing clindamycin phosphate 2% being developed for one-time vaginal administration for the treatment of BV.
