FSAD is clinically analogous to erectile dysfunction in men.
To date, there are no FDA-approved pharmacological treatments for FSAD; Daré's Sildenafil Cream has the potential to receive the first FDA approval for FSAD.
Market research estimates approximately 10 million women in the U.S. are distressed from experiencing symptoms associated with FSAD and are actively seeking solutions to improve their condition.
SAN DIEGO, Dec. 16, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in innovation for the health and wellbeing of women, and its collaborator Strategic Science & Technologies, LLC (SST), a Cambridge, MA based novel topical drug delivery company, today 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 (FSAD), reflecting U.S. Food and Drug Administration (FDA) feedback for safety and efficacy evaluations to support the indication of treatment of FSAD in premenopausal women.