The U.S. Food and Drug Administration granted qualified infectious disease product status to Daré Bioscience Inc.'s antibacterial gel for vaginal infections.
San Diego, Calif-based Daré is developing DARE-BV1, a thermosetting hydrogel containing clindamycin phosphate 2%, to treat bacterial vaginosis — a common infection caused by the overgrowth of bacteria naturally found in the vagina.
DARE-BV1 is a viscous liquid designed to undergo solution to gel transition using body temperature as the trigger, which allows the product to be more easily directed to the site of infection.
The approval was based on the company's proof-of-concept study, which showed that 86% of patients with bacterial vaginosis had no signs or symptoms of the disease after 7 to 14 days following a single administration of DARE-BV1.
Daré plans to initiate a phase 3 study of DARE-BV1 in about 250 women in the fourth quarter of 2019. Daré Bioscience said the phase 3 study is expected to be sufficient to secure an approval for DARE-BV1 as a treatment for bacterial vaginosis, based on the company's discussion with the FDA.
Qualified infectious disease designation is granted to drug candidates that treat serious infections, particularly those caused by bacteria and fungi that are resistant to treatment. The status allows for certain incentives to develop the therapies.