Dare Bioscience receives QIDP designation from FDA for DARE-BV1
Dare Bioscience announced that DARE-BV1, a novel thermosetting hydrogel containing clindamycin phosphate 2%, has been granted Qualified Infectious Disease Product designation by the U.S. Food and Drug Administration for the treatment of bacterial vaginosis in women. In an investigator-initiated proof-of-concept study, DARE-BV1 demonstrated an 86% clinical cure rate in the evaluable subjects at the test-of-cure visit after a single administration. Dare intends to commence a Phase 3 clinical study of DARE-BV1 in approximately 250 women in the fourth quarter of 2019. Based on prior discussions with the FDA, Dare believes that the Phase 3 study, if successful, would be sufficient for approval of DARE-BV1 to treat BV.