Daré Bioscience is set to commence Phase 3 clinical trials for Sildenafil Cream 3.6%, a novel topical treatment for Female Sexual Arousal Disorder (FSAD), following positive feedback from the U.S. Food and Drug Administration (FDA). The planned study aims to evaluate the safety and efficacy of the cream in premenopausal women, potentially addressing a significant unmet need in women's sexual health.
Addressing FSAD with Topical Sildenafil
FSAD is characterized by a persistent or recurrent inability to attain or maintain sufficient genital arousal during sexual activity, leading to distress or interpersonal difficulties. Market research indicates that approximately 10 million women in the U.S. aged 21 to 60 are affected by FSAD and are actively seeking solutions. Sildenafil Cream 3.6% is a proprietary formulation designed for on-demand topical application to the vulvar-vaginal tissue, increasing genital blood flow and improving arousal response while minimizing systemic side effects associated with oral sildenafil.
Sabrina Martucci Johnson, President and CEO of Daré Bioscience, highlighted the importance of addressing FSAD, stating, "While increased attention has been focused on female sexual dysfunctions over the past several years, no pharmacologic options have yet been FDA approved for FSAD, a condition which significantly compromises a woman's ability to have a pleasurable sexual experience."
Phase 3 Trial Design and Endpoints
The Phase 3 study will be a 12-week, double-blind, placebo-controlled trial. Consistent with the Phase 2b RESPOND study, the co-primary efficacy endpoints will assess arousal sensations and associated distress. Secondary endpoints will evaluate improvements in orgasm, desire, distress, and interpersonal difficulties. Daré Bioscience plans to submit the trial protocol and statistical analysis plan to the FDA in the first quarter of 2025, with the study expected to begin in mid-2025. A second confirmatory Phase 3 study will be required to support the New Drug Application (NDA) submission.
Sildenafil Cream: A Potential First-in-Category Treatment
Sildenafil, a phosphodiesterase-5 (PDE-5) inhibitor, is the active ingredient in Viagra, used to treat erectile dysfunction (ED) in men. FSAD is considered clinically analogous to ED, involving insufficient blood flow to the genitalia. If approved, Sildenafil Cream has the potential to be the first FDA-approved treatment for FSAD, creating a new market category within the female sexual dysfunction space.
Daré Bioscience is committed to advancing innovative products for women’s health, with a focus on contraception, sexual health, pelvic pain, fertility, infectious diseases, and menopause. Their portfolio includes XACIATO (clindamycin phosphate) vaginal gel 2% for bacterial vaginosis, Ovaprene, a hormone-free monthly intravaginal contraceptive, and DARE-HRT1, a combination intravaginal ring for menopausal hormone therapy.
