Daré Bioscience has opened nationwide telehealth consultations for DARE to PLAY, a topical sildenafil cream designed to enhance genital blood flow and arousal response in women. Through the DARE Health Hub, powered by Medvantx Pharmacy, women across all 50 U.S. states can now complete an online consultation to obtain a prescription – though we’re currently in a “pre-fulfillment” phase, meaning prescriptions are being written and held while pharmacy dispensing is expected to begin in the coming months.
Female sexual arousal disorder affects an estimated 20 million women in the U.S., yet there are currently no FDA-approved treatments for genital arousal, according to the company. DARE to PLAY is positioning itself as the first evidence-backed option in a space crowded with wellness products that lack clinical data. The cream uses sildenafil – the same active ingredient in Viagra – applied topically, and is backed by multiple clinical trials including a randomized, placebo-controlled study with 200 women. Clinical data shows increased genital blood flow within 10–15 minutes, with results published in Obstetrics & Gynecology and the Journal of Sexual Medicine.
Rather than waiting for full FDA approval (which Daré says it’s still pursuing), the company is bringing the product to market through a Section 503B outsourcing facility – manufactured under cGMP regulations and subject to FDA inspection, but not FDA-approved. It’s a pragmatic dual-path approach that could offer a playbook for other companies looking to bridge the gap between clinical evidence and commercial availability.
