Daré Bioscience Announces Phase 3 Plans for Sildenafil Cream, 3.6%, in the Treatment of Female Sexual Arousal Disorder (FSAD)

Core Insights - Daré Bioscience is developing Sildenafil Cream, a topical formulation of sildenafil, as a potential first FDA-approved treatment for female sexual arousal disorder (FSAD) [2][4][5] - Approximately 10 million women in the U.S. are affected by FSAD, indicating a significant market opportunity for effective treatments [6][4] - The company plans to initiate a Phase 3 clinical study in mid-2025, following FDA recommendations for evaluating safety and efficacy [3][9] Company Overview - Daré Bioscience focuses on innovative products for women's health, aiming to expand treatment options and improve outcomes in various areas including sexual health [11] - The company has previously launched XACIATO, a vaginal gel for bacterial vaginosis, and is developing other products like Ovaprene and DARE-HRT1 [12] Market Potential - FSAD is clinically similar to erectile dysfunction (ED) in men, with a notable prevalence among women, suggesting a substantial unmet need in the market [4][6] - The planned Phase 3 study will evaluate the efficacy of Sildenafil Cream against a placebo, with co-primary endpoints focusing on arousal sensations and associated distress [9][10] Clinical Development - The Phase 3 study will follow a 12-week double-blind treatment design, consistent with the previously completed Phase 2b RESPOND study [9][8] - Secondary endpoints will assess improvements in orgasm, desire, and interpersonal difficulties, further supporting the treatment's potential benefits [10][9]