Daré Bioscience Announces FDA Clearance of IND Application for DARE-BV1 for Bacterial Vaginosis to Commence Pivotal Phase 3 Clinical Study
Dare Bioscience, Inc. (DARE)
Last dare bioscience, inc. earnings: 8/14 04:01 pm
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Source: GlobeNewswire
SAN DIEGO, Dec. 18, 2019 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health innovation, today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for DARE-BV1, its novel thermosetting bioadhesive hydrogel containing 2% clindamycin phosphate being developed for one-time vaginal administration for the treatment of bacterial vaginosis (BV), a common but difficult to treat vaginal infection estimated to affect more than 20 million women in the United States.1 With the IND clearance from the FDA, Daré can commence the planned Phase 3 clinical study of DARE-BV1 in approximately 220 women in 2020 to support the New Drug Application (NDA) submission. Based on discussions with the FDA, the Phase 3 study will include a placebo control and assess the primary endpoint of clinical cure of BV (defined as resolution of specified clinical signs and symptoms from baseline visit) at the test-of-cure vi
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- Daré Bioscience Reports Full Year 2023 Financial Results and Provides Company UpdateGlobeNewswire
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