Dare Bioscience (DARE) announced plans for a Phase 3 study of Sildenafil Cream, 3.6%, an investigational topical cream formulation of sildenafil being developed as an on-demand treatment for female sexual arousal disorder, reflecting U.S. Food and Drug Administration feedback for safety and efficacy evaluations to support the indication of treatment of FSAD in premenopausal women. As an immediate next step, Dare will submit the protocol and statistical analysis plan for an adequate and well-controlled Phase 3 clinical study, reflecting the FDA’s recommendations, to the FDA in the first quarter of 2025, and is targeting mid-2025 for commencement of the Phase 3 study A second confirmatory Phase 3 study will be required to support the New Drug Application submission.
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