Posted by Michael Wonder on 12 Aug 2019
Daré Bioscience receives QIDP designation from the FDA for DARE-BV1 for the treatment of bacterial vaginosis
12 August 2019 - DARE-BV1 Phase 3 registrational trial initiation expected in 4th quarter 2019.
Daré Bioscience today announced that DARE-BV1, a novel thermosetting hydrogel containing clindamycin phosphate 2%, has been granted Qualified Infectious Disease Product (QIDP) designation by the U.S. FDA 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 (Day 7-14) after a single administration.
