Daré Bioscience, a leader in women’s health innovation, is making significant strides with its investigational product, Sildenafil Cream, 3.6%, designed to address Female Sexual Arousal Disorder (FSAD). FSAD is a condition characterized by a persistent inability to attain or maintain sufficient sexual arousal, leading to distress or interpersonal difficulties.
Currently, there are no FDA-approved treatments specifically for FSAD, highlighting the potential impact of Daré’s development.
Sildenafil Cream is a proprietary topical formulation of sildenafil, the active ingredient in Viagra®, tailored for women. Unlike oral formulations, this cream is applied directly to the vulvar-vaginal tissue, aiming to enhance genital blood flow and improve arousal response while minimizing systemic side effects. The product is being developed as an on-demand therapy, offering women a potential new option for managing FSAD.
In June 2023, Daré announced positive topline data from the exploratory Phase 2b RESPOND study, which evaluated the efficacy of Sildenafil Cream in women with FSAD. The study demonstrated meaningful improvements in sexual function, including arousal sensation, sexual satisfaction, lubrication and orgasm.
These findings support the continued development of Sildenafil Cream and inform the design of a Phase 3 study. Building on these results, Daré has initiated plans for a Phase 3 clinical study, incorporating feedback from the U.S. Food and Drug Administration (FDA). The study aims to further assess the safety and efficacy of Sildenafil Cream in premenopausal women with FSAD, with the goal of submitting a New Drug Application (NDA) upon successful completion.
Daré’s CEO is scheduled to present this innovative therapy at the upcoming Fierce Pharma Engage summit, focusing on breaking barriers and building access in women’s health. This presentation underscores the company’s commitment to addressing unmet needs in female sexual health and advancing novel treatment options.
With approximately 10 million women in the U.S. experiencing distress due to FSAD and actively seeking solutions, the development of Sildenafil Cream represents a significant advancement in women’s health. If approved, it has the potential to be the first FDA-approved treatment specifically for FSAD, offering hope to millions of women seeking effective therapy.
Disclaimer: This article is for informational purposes only and does not constitute medical advice. The Sildenafil Cream mentioned is still under investigation and has not yet been approved by the U.S. FDA for the treatment of FSAD. Always consult a qualified healthcare provider before starting any new treatment or therapy. Medosis Health does not endorse any specific product or treatment mentioned.
