DARE to PLAY sildenafil cream is now available for prescribing in select states as a non-hormonal topical option to improve genital blood flow and arousal.
DARE to PLAY is the first topical sildenafil cream developed for women and supported by exploratory randomized trial data.
The product is available as a compounded drug under Section 503B and is not FDA approved.
Prescribing access has begun in select states, with broader availability expected throughout 2025–2026.
Daré Bioscience announced commercial availability of DARE to PLAY sildenafil cream in select states, marking the first time a topical sildenafil formulation developed for women is being offered through a Section 503B outsourcing facility. The product uses sildenafil as a non-hormonal topical agent and was designed to increase genital blood flow and improve arousal sensations based on clinical studies, according to a company announcement.
DARE to PLAY is described as a proprietary topical sildenafil product formulated specifically for women to enhance genital blood flow and arousal response. According to the announcement, DARE to PLAY “represents the first and only evidence-backed sildenafil cream formulation for women,” and uses the same active ingredient found in sildenafil tablets. The company reported that genital blood flow increased in 10 to 15 minutes in studies and that clinical evaluations showed improvement in arousal sensations using clinically validated endpoints.
Sabrina Martucci Johnson, president and CEO of Daré Bioscience, stated that while sildenafil tablets changed sexual medicine for men, progress for women has been comparatively limited. “When Viagra was approved in 1998, it revolutionized sexual medicine for men. But for women, comparable progress on enhancing the natural arousal sensations has stalled for nearly three decades,” she said. “We believe DARE to PLAY™ represents a long overdue correction, giving women an option to reconnect with their own bodies, their pleasure, and their confidence, using science that finally recognizes their needs.”
The cream is administered topically and is intended for use as needed at the time of sexual activity. The company stated the drug acts locally to enhance the natural arousal response without systemic effects. Existing products marketed for arousal have relied largely on consumer-oriented promotion, the company said, whereas its product has been supported by toxicology evaluations and randomized clinical studies.
Research findings have been published in Obstetrics & Gynecology and the Journal of Sexual Medicine,2 according to Daré Bioscience. Irwin Goldstein, MD, director of San Diego Sexual Medicine, stated, “As more women speak openly about their sexual health, the need for research-backed solutions has never been greater,” and “Daré’s commitment to both clinical integrity and timely access ensures women who need it don’t have to wait to benefit from this innovation.”
In a phase 2b randomized, placebo-controlled trial enrolling 200 premenopausal women with female sexual arousal disorder, investigators evaluated 3.6% topical sildenafil over 12 weeks. In the intention-to-treat population, improvements in the Arousal Sensation domain of the Sexual Function Questionnaire were greater in the sildenafil arm but did not reach statistical significance versus placebo for the coprimary endpoints. However, exploratory analyses identified a subset of women with female sexual arousal disorder either alone or with decreased desire, who demonstrated significant improvements in sexual arousal sensation and trends toward improvements in desire and orgasm domains, along with reduced sexual distress in selected Female Sexual Distress Scale questions.2
The product is being provided as a Section 503B compounded drug manufactured under current Good Manufacturing Practice requirements and subject to U.S. Food and Drug Administration inspection. Compounded products are not FDA approved, and the FDA does not evaluate compounded products for safety, effectiveness, or quality. According to the announcement, the company intends to continue activities necessary to seek full FDA approval in the future.
Prescriptions are currently available for pre-order in Connecticut, Florida, Indiana, Missouri, New Hampshire, New Jersey, Oregon, Pennsylvania, Rhode Island, and Utah, with shipments expected within 45 days of order placement. Additional state availability is expected in late 2025 and early 2026.
The company noted that approximately 20 million women in the United States report challenges related to genital arousal and that no FDA-approved therapeutic agents directly target this need. The availability of a clinically evaluated topical sildenafil option may provide a new pathway for women presenting with reduced genital arousal or decreased genital blood flow. The company described the launch as an example of ongoing efforts to narrow treatment disparities in women’s health.
The product will be distributed through Medvantx as part of the DARE Health Hub platform. Additional product information and prescribing logistics are available through the manufacturer’s website, including updates on availability by state.
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