Sildenafil cream for female sexual arousal disorder available to prescribe in select states

DARE to PLAY, a proprietary topical arousal cream designed to enhance genital blood flow and arousal response in women, can now be prescribed in select states, manufacturer Daré Bioscience, Inc announced in a news release.¹

“When Viagra [sildenafil citrate] 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 3 decades,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience, in the news release. “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.”¹

As the company continues the process to seek FDA approval of the sildenafil cream formulation, it is making the cream available in the form of a Section 503B compounded product. Although the sildenafil cream is manufactured “in an outsourcing facility subject to FDA inspection and under current Good Manufacturing Practice regulations,” Daré Bioscience noted that compounded drugs are not FDA approved or evaluated by the agency for “safety, effectiveness, or quality.”¹

DARE to PLAY is currently available for prescription for pre-order in Connecticut, Florida, Indiana, Missouri, New Jersey, Oregon, Pennsylvania, Rhode Island, and Utah. Daré Bioscience said the sildenafil cream’s availability will expand to other states throughout December 2025 and early 2026.¹

DARE to PLAY has been evaluated in several studies, including a phase 2b randomized controlled trial (NCT04948151), the results of which were published in Obstetrics & Gynecology. In that study, 200 women with female sexual arousal disorder (FSAD) were randomly assigned to receive the sildenafil cream or placebo cream. The co-primary efficacy end points included change from baseline to week 12 in the Arousal Sensation domain of the Sexual Function Questionnaire (SFQ28), as well as question 14 of the Female Sexual Distress Scale—Desire, Arousal, Orgasm (FSDS-DAO).²

Greater improvement in SFQ28 Arousal Sensation domain scores was observed in patients receiving sildenafil cream, although “there were no statistically significant differences between sildenafil and placebo cream users in the coprimary and secondary efficacy end points,” wrote the authors. The investigators also conducted an exploratory post hoc analysis evaluating a subset of the intention-to-treat population who had a diagnosis of FSDD with or without concomitant decreased desire. In this subset, significant increases in SFQ28 Arousal Sensation domain score were seen vs the placebo group.

These patients also had a higher mean improvement in SFQ28 Desire and Orgasm domain scores, as well as significantly decreased sexual distress and interpersonal difficulties as assessed by FSDS-DAO questions 3, 5, and 10.²

“As more women speak openly about their sexual health, the need for research-backed solutions has never been greater,” said Irwin Goldstein, MD, director of San Diego Sexual Medicine in California and a founder of the International Society for the Study of Women’s Sexual Health in the news release. “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.”¹

REFERENCES

1. DARE to PLAY sildenafil cream now available for pre-order by prescription: First evidence-based topical arousal cream for women begins commercial rollout in select states via 503B outsourcing facility. News release. Daré Bioscience, Inc. December 10, 2025. Accessed December 10, 2025. https://ir.darebioscience.com/news-releases/news-release-details/dare-playtm-sildenafil-cream-now-available-pre-order

2. Preliminary efficacy of topical sildenafil cream for the treatment of female sexual arousal disorder: A randomized controlled trial. Obstet Gynecol. 2024;144(2):144-152. doi:10.1097/AOG.0000000000005648