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Daré Bioscience Announces Positive Topline Results From DARE-BVFREE, a Phase 3 Trial of DARE-BV1 in Patients Diagnosed with Bacterial Vaginosis
DARE-BV1 met the primary endpoint of the study and all pre-specified secondary efficacy endpoints; demonstrated significantly greater clinical cure rates
About this update from Dare Bioscience, Inc.
[{"type":"text","content":"DARE-BV1 met the primary endpoint of the study and all pre-specified secondary efficacy endpoints; demonstrated significantly greater clinical cure rates compared to placebo DARE-BV1 has Fast Track and QIDP designations from FDA New drug application (NDA) submission planned 1H of 2021 SAN DIEGO, Dec. 07, 2020 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced positive topline results from the DARE-BVFREE Phase 3 randomized, double-blinded, placebo-controlled clinical trial evaluating DARE-BV1 in 307 women diagnosed with bacterial vaginosis, a serious condition estimated to affect approximately 21 million women in the United States. DARE-BV1 is an investigational thermosetting bioadhesive hydrogel containing clindamycin phosphate 2% designed as a convenient, one-time vaginally-administered treatment for bacterial vaginosis. The trial met its primary endpoint demonstrating that a single administration of DARE-BV1 was superior to placebo as a primary therapeutic intervention for women diagnosed with bacterial vaginosis. “Based on these topline results, DARE-BV1 delivered clinical cure rate values greater than those of currently marketed FDA-approved products for the treatment of bacterial vaginosis. This successful Phase 3 clinical trial marks another important achievement for Daré. We began 2020 with the announcement of a commercial partnership for Ovaprene® with Bayer, marketer of one of the most successful contraceptive products in women’s health, and we’re concluding the year with another exciting milestone, the successful completion of our Phase 3 clinical trial of DARE-BV1 to support an NDA for the treatment of bacterial vaginosis,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “We believe there is a large unmet need for a more efficacious and convenient, single-dose vaginally-administered product to treat bacterial vaginosis, and we believe DARE-BV1 could become a new front-line treatment option. DARE-BV1 received Fast Track designation from the FDA earlier this year and, based on the topline results of this trial, we plan to file our NDA in the first half of 2021.” Topline Results of the Phase 3 Randomized Clinical TrialDARE-BVFREE randomized 307 women at 32 centers across the United States in a 2:1 ratio to receive a single vaginal dose of...