Daré Bioscience Publishes Positive Sildenafil Cream Safety Findings in The Journal of Sexual Medicine

Topical Sildenafil Cream, 3.6% has been demonstrated to be safe and well-tolerated for use by women and their partners across 1,357 sexual experiences, according to recent data. Unlike oral sildenafil, the topical formulation did not lead to common side effects such as headache and flushing in women.

Daré Bioscience, Inc., a company focused on women's health, announced that findings from their Phase 2b RESPOND clinical study on Sildenafil Cream, 3.6% have been published in The Journal of Sexual Medicine. This study was an exploratory investigation aimed at evaluating the safety and tolerability of the topical cream in treating female sexual arousal disorder (FSAD).

The study, authored by Thurman et al., is titled "Safety of topical sildenafil cream, 3.6% in a randomized, placebo-controlled trial for the treatment of female sexual arousal disorder" and is available in the 2024 edition of The Journal of Sexual Medicine. The publication highlights that the safety dataset is particularly robust as it includes data from both participants and their partners.

Dr. Annie Thurman, the lead author and Medical Director at Daré Bioscience, noted that the study showed the topical formulation was well-tolerated. She pointed out that oral sildenafil is associated with hypotensive effects, leading to side effects like headache, flushing, nausea, and dizziness, which were not observed with the topical application. This reduced side effect profile is likely due to the significantly lower systemic exposure from the cream compared to oral sildenafil.

The 12-week RESPOND study involved healthy premenopausal women with FSAD and their sexual partners. It demonstrated that the cream was safe and well-tolerated, with no significant differences in treatment-emergent adverse events compared to a placebo. The study was designed to identify the patient population that showed the most meaningful improvement from the cream and to determine the most reflective patient-reported outcome measures.

Daré Bioscience is in ongoing discussions with the FDA and is conducting operational activities to support the planned Phase 3 program for Sildenafil Cream. Previous efficacy data from the Phase 2b study have also been published in Obstetrics & Gynecology.

FSAD is characterized by a persistent or recurrent inability to achieve or maintain adequate genital arousal during sexual activity, resulting in distress or interpersonal difficulty. This condition is clinically similar to erectile dysfunction (ED) in men and is associated with insufficient genital blood flow.

Sildenafil, known commercially as Viagra for ED, is a phosphodiesterase-5 (PDE-5) inhibitor. Sildenafil Cream is a proprietary topical formulation designed to be applied to vulvar-vaginal tissue to enhance genital blood flow and improve arousal response in women, circumventing the systemic side effects of oral sildenafil.

Market research indicates that approximately 16% of women in the U.S. aged 21 to 60, or about 10 million women, experience distress due to FSAD symptoms and are seeking effective treatments. By comparison, about 5% of men at age 40, increasing to 15% at age 70, experience complete ED.

Daré Bioscience's mission is to advance innovative products for women's health, covering areas such as contraception, vaginal health, reproductive health, menopause, sexual health, and fertility. Their portfolio includes XACIATO™ for bacterial vaginosis, Ovaprene® for contraception, and DARE-HRT1 for menopausal hormone therapy.

The company's leadership has received recognition in various industry lists and awards, highlighting their contributions to women’s health innovation and advocacy. Daré Bioscience continues to focus on developing new treatments that improve health outcomes for women.

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