Daré Bioscience, Inc. (NASDAQ: DARE) has announced plans to accelerate market access for its proprietary Sildenafil Cream formulation through a novel dual-path approach, with availability via prescription targeted for Q4 2025. The company's President and CEO, Sabrina Martucci Johnson, will present this expanded business strategy at the upcoming Jones Healthcare and Technology Innovation Conference on April 9th.
Strategic Dual-Path Approach for Women's Health Innovation
The biopharmaceutical company, focused on women's health, is implementing a strategy to integrate Section 503B compounding as part of its approach to bring select proprietary formulations to market more rapidly. This decision comes in response to significant demand from both the healthcare community and women seeking effective treatments for female sexual arousal disorder (FSAD).
"We are actively evaluating a dual-path approach for some of the other proprietary formulations as part of our responsibility to women, to the healthcare community, and to our shareholders," said Johnson. "In addition, we may also bring to market consumer health products that can be obtained without a physician's prescription."
The company plans to provide updates on timing and strategic partnerships to achieve these objectives within the current quarter.
Addressing Unmet Needs in Female Sexual Health
Sildenafil Cream, 3.6% is a novel topical formulation of sildenafil, the same active ingredient found in Viagra®, being developed specifically for the treatment of FSAD. This condition is clinically analogous to erectile dysfunction in men, yet currently has no FDA-approved pharmacological treatments.
Market research estimates approximately 10 million women in the U.S. are distressed from experiencing symptoms associated with FSAD and are actively seeking solutions. The cream formulation represents a potential first-in-category treatment that could significantly impact women's sexual health.
Clinical Evidence Supporting Safety and Efficacy
Recent publications in The Journal of Sexual Medicine have highlighted positive findings from the Phase 2b RESPOND clinical study of Sildenafil Cream. The data demonstrated that the topical formulation was safe and well-tolerated by women and their partners across 1,357 sexual experiences, without producing common side effects associated with oral sildenafil use in women, such as headache and flushing.
Additional analyses showed that age and use of hormonal contraception did not impact the efficacy of Sildenafil Cream, supporting its potential broad applicability. The study also validated that both 1-month and 24-hour recall patient reported outcome instruments could effectively assess treatment efficacy in future clinical studies.
Broader Portfolio and Business Strategy
Daré's expanded business strategy extends beyond Sildenafil Cream to potentially include other proprietary formulations that could be provided through the Section 503B framework of the Federal Food, Drug, and Cosmetic Act (FDCA).
The company's portfolio includes several other potential first-in-category candidates in clinical development:
- Ovaprene®, a hormone-free monthly intravaginal contraceptive with U.S. commercial rights licensed to Bayer
- DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for menopausal hormone therapy
- XACIATO™, an FDA-approved treatment for bacterial vaginosis under global license with Organon
Financial and Strategic Positioning
To support its expanded strategy, Daré recently entered into a $15 million common stock purchase agreement with Lincoln Park Capital Fund, LLC, providing access to capital at the company's discretion. These funds could help advance the Phase 3 program for Sildenafil Cream and other portfolio initiatives.
The company has also implemented a 1-for-12 reverse stock split of its common shares to regain compliance with Nasdaq's minimum bid price requirements, ensuring continued listing on the exchange.
Industry Recognition
Daré's leadership in women's health innovation has garnered significant recognition, with company leadership being named on the Medicine Maker's Power List and Endpoints News' Women in Biopharma. Johnson has also been honored as one of Fierce Pharma's Most Influential People in Biopharma for the company's contributions to innovation and advocacy in women's health.
As Daré continues to challenge the status quo in women's health, the company's dual-path approach represents a strategic pivot to accelerate access to innovative treatments while maintaining its commitment to evidence-based solutions for decades of unmet needs.
