New Sildenafil Cream for Women Aims to Close a Major Health Gap

SAN DIEGO, CA – February 11, 2026 – In a move poised to address one of the most significant unmet needs in women's health, Daré Bioscience today announced the nationwide availability of telehealth consultations for DARE to PLAY™, a proprietary topical sildenafil cream. The product is the first of its kind to be developed with clinical evidence specifically for improving female sexual arousal. This launch allows women across all 50 U.S. states to begin the process of obtaining a prescription, marking a critical step toward closing a long-standing gender gap in sexual medicine.

For decades, while the market for male sexual dysfunction has flourished, women seeking solutions for arousal issues have been met with limited, often ineffective options. DARE to PLAY™ represents a direct challenge to this disparity, offering a science-backed, non-hormonal cream designed to enhance genital blood flow and arousal response locally and on demand.

Addressing a Long-Ignored Need

An estimated 20 million women in the United States experience challenges with genital arousal, a condition that can significantly impact quality of life, emotional well-being, and intimate relationships. Yet, there are currently no FDA-approved therapeutics specifically designed to address this physiological need. Existing approved treatments for female sexual dysfunction, such as Addyi and Vyleesi, are systemic drugs that target neurotransmitters in the brain to increase sexual desire, not the physical mechanics of arousal.

DARE to PLAY™ enters this void with a fundamentally different approach. By using sildenafil, the same active ingredient found in Viagra®, in a topical cream, it aims to increase blood flow directly to the genital tissue where it is applied. This localized action is designed to work in conjunction with a woman's natural arousal cues within 10-15 minutes, without the systemic side effects often associated with oral medications.

"Many women experience sexual health concerns but have not yet connected with a healthcare provider about them,” said Sabrina Johnson, President and Chief Executive Officer of Daré Bioscience, in a statement. "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 introduction of an evidence-based option is a significant departure from the current landscape, which is dominated by lifestyle products and supplements that often lack rigorous clinical validation. Daré Bioscience emphasizes that its product is backed by toxicology studies and multiple clinical trials in women, with research published in peer-reviewed medical journals.

The Science Behind a Familiar Drug Reimagined

The innovation behind DARE to PLAY™ lies in its formulation and targeted application. While sildenafil is a well-understood PDE5 inhibitor that works by increasing blood flow, its use in women has been a subject of study for years. Daré's approach focuses on delivering the drug topically to avoid systemic absorption and concentrate its effects where they are needed most.

The company's Phase 2b RESPOND clinical trial, which studied the cream in 200 premenopausal women with Female Sexual Arousal Disorder (FSAD), provides the core evidence for the product. Safety data published in The Journal of Sexual Medicine found the 3.6% sildenafil cream to be safe and well-tolerated by both the women using it and their sexual partners, with a notable absence of common oral sildenafil side effects like headaches or flushing.

The efficacy findings, published in Obstetrics & Gynecology (the official publication of ACOG), presented a more nuanced picture that is guiding the product's future. While the trial did not meet its primary endpoints in the overall study population, a pre-planned exploratory analysis of a specific subgroup yielded highly encouraging results. In women whose primary issue was FSAD (with or without a secondary issue of low desire), the cream showed statistically significant improvements in arousal sensation, desire, and orgasm, along with a reduction in sexual distress. This suggests the cream is most effective for a clearly defined patient profile, a critical insight that will shape the design of future Phase 3 trials required for full FDA approval.

A Dual Strategy for Patient Access

To bring DARE to PLAY™ to women now, Daré is employing an innovative dual-pathway strategy. The product is being made available initially as a compounded drug under Section 503B of the Federal Food, Drug, and Cosmetic Act. This allows the cream to be produced by a registered "outsourcing facility" that is subject to FDA inspection and must adhere to Current Good Manufacturing Practice (cGMP) regulations, ensuring quality and consistency.

This 503B pathway enables earlier patient access for a medication addressing an unmet need, but it is important for consumers to understand the distinction. Compounded drug products are not FDA-approved, meaning the agency has not independently verified their safety, effectiveness, or quality through its rigorous New Drug Application process.

Daré's strategy uses this pathway as a bridge. While women gain access to the cGMP-manufactured cream, the company will continue to pursue full FDA approval. This approach allows Daré to build market awareness and gather real-world data while navigating the lengthy and expensive traditional approval process, a maneuver that could become a model for other companies in the women's health space.

How to Get DARE to PLAY™

Effective immediately, women interested in the treatment can begin the prescription process through the DARE Health Hub, a telehealth platform powered by Medvantx Pharmacy. This allows for a discreet and convenient consultation with a healthcare provider via a secure online questionnaire, eliminating the need for an in-person appointment.

The company has initiated a "pre-fulfillment prescription period." During this time, women who receive a prescription will be eligible for several benefits, including a complimentary telehealth visit (a $30 value) and a 25% discount on their initial order and subsequent refills. Their prescriptions will be securely held by Medvantx and given priority access once pharmacy dispensing begins in their state in the coming months.

This pre-fulfillment period allows the 503B outsourcing facility to plan production and manage state-by-state licensing based on prescribing interest, a move designed to ensure a smooth and reliable supply chain once the product becomes available for shipping. Prescriptions will be fulfilled on a first-come, first-served basis according to when they are received at the pharmacy, making this early access period a key opportunity for interested patients.