Daré Bioscience Launches First Evidence-Based Topical Sildenafil Cream for Women's Sexual Health
核心洞察
Daré Bioscience has launched DARE to PLAY™ Sildenafil Cream, the first evidence-based topical arousal cream specifically developed for women, now available by prescription in 10 U.S. states.
The non-hormonal cream uses sildenafil to increase genital blood flow within 10-15 minutes and improve arousal sensations, backed by clinical trials including a randomized placebo-controlled study with 200 women.
The product addresses a significant unmet medical need, as an estimated 20 million women in the United States experience challenges related to genital arousal with no FDA-approved therapeutics currently available.
Daré Bioscience announced the commercial launch of DARE to PLAY™ Sildenafil Cream, marking the first evidence-based topical arousal treatment specifically developed for women. The prescription cream is now available for pre-order in 10 states, representing a significant advancement in addressing women's sexual health needs that have been largely overlooked for decades.
The topical formulation uses sildenafil, the same active ingredient found in Viagra, to enhance genital blood flow and arousal response. Clinical studies demonstrate the cream increases genital blood flow within 10-15 minutes and improves arousal sensations based on clinically-validated endpoints, providing women with a non-hormonal, as-needed treatment option.
Clinical Evidence and Development
DARE to PLAY™ distinguishes itself from existing arousal products through rigorous scientific validation. The formulation is supported by comprehensive toxicology studies covering oral, anal, vaginal, and reproductive health, along with multiple clinical trials in women, including a randomized placebo-controlled study involving 200 women and their sexual partners.
The research has been published in peer-reviewed medical journals, including The Green Journal, the official publication of the American College of Obstetrics and Gynecology (ACOG), and the Journal of Sexual Medicine, the official publication of the International Society for the Study of Women's Sexual Health (ISSWSH).
"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," said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. "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."
Market Access and Regulatory Pathway
The cream is currently available as a Section 503B compounded product, manufactured in an outsourcing facility subject to FDA inspection and under current Good Manufacturing Practice (cGMP) regulations. This approach allows for immediate market access while the company continues activities necessary to seek FDA approval of its proprietary sildenafil cream formulation.
Healthcare providers can now prescribe DARE to PLAY™ for pre-order in Connecticut, Florida, Indiana, Missouri, New Hampshire, New Jersey, Oregon, Pennsylvania, Rhode Island, and Utah, with shipping expected within 45 days during the pre-order phase. The product will expand to additional states throughout December and early 2026.
Dr. Irwin Goldstein, Director of San Diego Sexual Medicine and a founder of ISSWSH, emphasized the significance of the launch: "As more women speak openly about their sexual health, the need for research-backed solutions has never been greater. 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."
Addressing an Unmet Medical Need
The launch addresses a substantial gap in women's healthcare. An estimated 20 million women in the United States experience challenges related to genital arousal, yet no FDA-approved therapeutics exist to address this need. The availability of DARE to PLAY™ through a cGMP 503B facility provides this underserved population access to a product supported by clinical evidence and scientific rigor.
Unlike existing products that rely primarily on marketing language and consumer reviews, DARE to PLAY™ represents the first topical sildenafil formulation developed specifically for women with comprehensive clinical backing. The cream is designed for topical application to enhance the body's natural arousal response without systemic effects.
Company Focus on Women's Health
Daré Bioscience positions itself as a purpose-driven health biotech company focused exclusively on closing gaps in women's health between promising science and real-world solutions. The company's approach emphasizes rigorous clinical development, including randomized controlled trials, validated endpoints, peer-reviewed publications, and cGMP manufacturing requirements.
The launch of DARE to PLAY™ represents a significant milestone in the company's mission to address critical gaps in women's healthcare, spanning areas from contraception to menopause, pelvic pain to fertility, and vaginal health to infectious disease.