Daré Bioscience Publishes Phase 2b Results of Topical Sildenafil for Female Sexual Arousal Disorder in Obstetrics & Gynecology

SAN DIEGO, June 24, 2024 - DARÉ Bioscience Inc. (NASDAQ: DARE), a prominent figure in women's health innovation, has unveiled the publication of its Phase 2b study results for Sildenafil Cream 3.6% in the journal Obstetrics & Gynecology. The cream, designed for treating female sexual arousal disorder (FSAD), has shown promising outcomes, particularly in women with FSAD who also experience decreased desire.

The Phase 2b trial was a comprehensive, multi-center, double-blind, placebo-controlled study aimed at evaluating the preliminary efficacy and safety of Sildenafil Cream, 3.6%, in premenopausal women with FSAD. Results demonstrated that the topical application significantly improved sexual arousal and reduced sexual distress, especially in a subset of women experiencing both FSAD and decreased desire. Moreover, it enhanced overall sexual desire and orgasmic function.

Dr. Annie Thurman, Medical Director at Daré Bioscience, highlighted the significance of these findings, noting that FSAD affects about 20% of women in the U.S. 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.

Sabrina Martucci Johnson, President and CEO of Daré Bioscience, expressed her satisfaction with the manuscript’s acceptance, stating that these groundbreaking data could advance the understanding and treatment of FSAD. The positive results from this study are expected to pave the way for further clinical development and regulatory discussions.

The company had 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 treatment. Daré Bioscience is in ongoing discussions with the FDA to finalize the design for Phase 3 pivotal trials, which will be crucial for product registration and labeling.

FSAD is defined by the DSM-IV as a condition characterized by a persistent or recurrent inability to achieve or maintain adequate genital arousal, often leading to distress or interpersonal difficulties. It is analogous to erectile dysfunction in men and involves insufficient blood flow to the genital area. Sildenafil, the active ingredient in Viagra®, is a PDE-5 inhibitor that enhances blood flow. The investigational Sildenafil Cream aims to provide localized treatment to improve genital arousal without the systemic side effects of oral Viagra®.

Research indicates that around 16% of women in the U.S., roughly 10 million, suffer from symptoms of FSAD and are seeking effective treatments. Comparatively, complete erectile dysfunction affects about 5% of men at age 40, rising to 15% by age 70.

Daré Bioscience is dedicated to developing innovative health products for women, with a diverse portfolio targeting areas such as contraception, vaginal health, reproductive health, menopause, sexual health, and fertility. Their first FDA-approved product, XACIATO™ (clindamycin phosphate) vaginal gel 2%, treats bacterial vaginosis and is commercially available through a partnership with Organon. Other promising candidates in Daré’s pipeline include Ovaprene®, a hormone-free contraceptive, and DARE-HRT1, a hormone therapy ring for menopause.

Daré Bioscience has received significant recognition for its contributions to women's health, with its leadership featured on prestigious lists such as the Medicine Maker’s Power List and Fierce Pharma’s Most Influential People in Biopharma. The company also earned the top spot in the San Diego Business Journal’s 2023 Best Places to Work Awards in the Small Company category.