DARE to PLAY FDA Approval Status
Last updated by Judith Stewart, BPharm on Aug 12, 2025.
FDA Approved: No
Brand name: DARE to PLAY
Generic name: sildenafil
Dosage form: Topical Cream
Company: Daré Bioscience, Inc.
Treatment for: Hypoactive Sexual Desire Disorder
DARE to PLAY (sildenafil) is a topical cream formulation of sildenafil (the active ingredient in Viagra) in development for the treatment of female sexual arousal disorder.
- Female sexual arousal disorder (FSAD) is described in the Diagnostic and Statistical Manual 4th Edition (DSM-IV) as a condition characterized as a persistent or recurrent inability to attain or maintain sufficient genital arousal (an adequate lubrication-swelling response) during sexual activity, frequently resulting in distress or interpersonal difficulty.
- Sildenafil is a phosphodiesterase-5 (PDE-5) inhibitor that was first approved in an oral formulation under the brand name Viagra in 1998 for the treatment of erectile dysfunction in men. It is thought that using sildenafil to direct blood to the genitals before sexual activity could provide a potential improvement in genital arousal response and overall sexual experience for women as it does in men.
- Sildenafil Cream is applied locally to the vaginal tissue and is designed to facilitate vasodilation and increased blood flow directly to the genital tissue to improve the physical arousal response symptoms commonly associated with FSAD while avoiding systemic side effects observed with oral formulations of sildenafil.
- The exploratory Phase 2b RESPOND Study designed to evaluate Sildenafil Cream versus placebo over 12 weeks of double-blinded dosing was completed in 2023. The Sildenafil Cream-treated group showed meaningful improvement in the co‑primary endpoint assessment that evaluated change from baseline in the Arousal-Sensation Domain of the Sexual Function Questionnaire, although the endpoint did not achieve statistical significance. Post-hoc analyses showed that Sildenafil Cream met the Ph2b co-primary endpoint (SFQ28-arousal domain patient reported outcome (PRO)) and demonstrated clinically meaningful benefit in patients who have FSAD or FSAD with concomitant decreased desire.
- Daré Bioscience, Inc. intends to leverage the existing safety and efficacy data for sildenafil to utilize the FDA’s 505(b)(2) pathway to obtain marketing approval of Sildenafil Cream, 3.6% in the U.S. for the treatment of women with FSAD.
Development timeline for DARE to PLAY
Further information
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