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Daré Bioscience Announces FDA Acceptance and Priority Review of New Drug Application for DARE-BV1 for the Treatment of Bacterial Vaginosis
Six-month priority review granted for DARE-BV1 with PDUFA target action date set for December 7, 2021.NDA supported by positive data from the DARE-BVFREE
About this update from Dare Bioscience, Inc.
[{"type":"text","content":"Six-month priority review granted for DARE-BV1 with PDUFA target action date set for December 7, 2021.NDA supported by positive data from the DARE-BVFREE Phase 3 study, which demonstrated clinical cure rates of 70-81% from a single vaginal dose of DARE-BV1.Ongoing strategic discussions underway to support a robust market introduction of the product in 2022, if approved. SAN DIEGO, Aug. 09, 2021 (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) accepted for filing the company’s New Drug Application (NDA) for DARE-BV1 for the treatment of bacterial vaginosis. The FDA granted this application Priority Review and set a Prescription Drug User Fee Act (PDUFA) date of December 7, 2021 for the target completion of its review of the NDA. The FDA grants Priority Review to applications for potential drugs that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment of a serious condition. The NDA is supported by positive results from the DARE-BVFREE Phase 3 randomized, multi-center, double-blinded, placebo-controlled clinical trial evaluating DARE-BV1 in women diagnosed with bacterial vaginosis, a condition that can cause serious health risks and very disruptive symptoms and is 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 one-time vaginally-administered treatment for bacterial vaginosis. \"The acceptance of this NDA marks a major milestone not only for Daré as a company but importantly for the 21 million women impacted by bacterial vaginosis,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “It is our goal to bring to market a product that has the potential to improve outcomes and convenience for women, as DARE-BV1 demonstrated it has the potential to do in the Phase 3 study, where a single vaginal dose of DARE-BV1 achieved clinical cure rates of 70-81%.\" The results from the DARE-BVFREE study demonstrated DARE-BV1’s potential to provide improved clinical cure rates in a convenient, one-time dose compared to those of currently branded FDA-approved products indicated for the treatment of bacterial vaginosis. Patients in th...