Daré Bioscience Publishes Positive Phase 2b Results for Topical Sildenafil Cream in Female Sexual Arousal Disorder
Key Insights
Daré Bioscience published Phase 2b results for Sildenafil Cream 3.6% (search) in Obstetrics & Gynecology, showing significant improvement in sexual arousal and reduced distress in women with female sexual arousal disorder (search).
The topical cream demonstrated particular efficacy in premenopausal women with both FSAD (search) and decreased desire, enhancing overall sexual desire and orgasmic function without systemic side effects.
Following a successful end-of-Phase 2 FDA meeting, the company is advancing toward Phase 3 pivotal trials to address an unmet medical need affecting approximately 10 million women in the U.S.
Daré Bioscience Inc. (NASDAQ: DARE) has published promising Phase 2b clinical trial results for its investigational Sildenafil Cream 3.6% (search) in the journal Obstetrics & Gynecology, marking a significant milestone in the development of treatments for female sexual arousal disorder (search) (FSAD (search)). The topical formulation demonstrated statistically significant improvements in sexual arousal and reduced sexual distress, particularly in women experiencing both FSAD and decreased desire.
Phase 2b Trial Results Show Clinical Promise
The comprehensive, multi-center, double-blind, placebo-controlled Phase 2b RESPOND study evaluated the preliminary efficacy and safety of Sildenafil Cream 3.6% (search) in premenopausal women with FSAD (search). Results showed that the topical application significantly improved sexual arousal and reduced sexual distress, with enhanced overall sexual desire and orgasmic function observed in the treatment group.
"FSAD (search) affects about 20% of women in the U.S.," noted Dr. Annie Thurman, Medical Director at Daré Bioscience. "The publication in a reputable medical journal underscores the potential of Sildenafil Cream to address this unmet medical need and improve sexual health outcomes for women suffering from FSAD."
The exploratory Phase 2b study was specifically designed to identify the patient population that experienced the most meaningful improvement from Sildenafil Cream and determine the most appropriate patient-reported outcome measures to assess treatment efficacy.
Addressing a Significant Unmet Medical Need
FSAD (search), as defined by the DSM-IV, is characterized by a persistent or recurrent inability to achieve or maintain adequate genital arousal, often leading to distress or interpersonal difficulties. The condition is clinically analogous to erectile dysfunction (search) in men and involves insufficient blood flow to the genital area.
Market research indicates that approximately 16% of women in the U.S. ages 21 to 60, representing roughly 10 million women, experience distress from symptoms associated with FSAD (search) and are actively seeking effective treatments. In comparison, complete erectile dysfunction (search) affects about 5% of men at age 40, rising to 15% by age 70.
Novel Topical Approach Avoids Systemic Side Effects
Sildenafil Cream represents an innovative approach to treating FSAD (search) through localized delivery. The investigational cream contains sildenafil, a phosphodiesterase-5 (search) (PDE-5 (search)) inhibitor and the active ingredient in Viagra®, formulated for topical administration to vulvar-vaginal tissue. This approach aims to increase genital blood flow and improve the female genital arousal response while avoiding the systemic side effects associated with oral sildenafil formulations.
Validated Patient Assessment Methods
Additional data from the Phase 2b study, published in The Journal of Sexual Medicine, demonstrated that responses from 1-month and 24-hour recall patient-reported outcome instruments were similar, supporting that either method could be used to assess treatment efficacy in future clinical studies. This finding is particularly significant as longer recall intervals are less burdensome to clinical study participants and may improve data collection compliance.
"Being able to show consistent results from patient reported outcome measures, regardless of whether she is recalling her experiences over the last month or the last day, provides important optionality as we consider how to clinically measure the impact of Sildenafil Cream on patients with FSAD (search)," said Sabrina Martucci Johnson, President and CEO of Daré Bioscience.
Regulatory Progress and Future Development
Daré Bioscience previously announced a successful end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), supporting the advancement of Sildenafil Cream for FSAD (search) treatment. The company continues ongoing discussions with the FDA to finalize the design for Phase 3 pivotal trials, which will be crucial for product registration and labeling.
The patient population and endpoints proposed to the FDA for Phase 3 clinical development were identified through exploratory post-hoc analyses of the Phase 2b study data, where Sildenafil Cream demonstrated statistically significant and meaningful patient improvement.
Company Portfolio and Recognition
Daré Bioscience is dedicated to developing innovative health products for women, with a diverse portfolio targeting contraception, vaginal health, reproductive health, menopause, sexual health, and fertility. The company's first FDA-approved product, XACIATO™ (clindamycin phosphate) vaginal gel 2%, treats bacterial vaginosis (search) and is commercially available through a partnership with Organon.
The company has received significant recognition for its contributions to women's health, with leadership featured on prestigious lists including the Medicine Maker's Power List and Fierce Pharma's Most Influential People in Biopharma. Daré Bioscience also earned the top spot in the San Diego Business Journal's 2023 Best Places to Work Awards in the Small Company category.