Daré Bioscience Publishes Positive Phase 2b RESPOND Study Results of Sildenafil Cream in The Journal of Sexual Medicine

Newly published data highlights the effectiveness of using both 1-month and 24-hour recall patient-reported outcome (PRO) instruments in assessing treatment efficacy. The findings, revealed by Daré Bioscience, Inc., a leader in women's health innovation, suggest that either recall method can reliably measure the impact of treatments in future clinical studies. Longer recall intervals, such as the 1-month PRO, are less taxing for participants and might enhance data collection compliance.

Daré Bioscience recently announced additional data from its exploratory Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6%. This investigational topical cream is being developed as an on-demand treatment for Female Sexual Arousal Disorder (FSAD). The Journal of Sexual Medicine has published these findings in a paper titled “Comparisons and correlations of 1-month recall vs 24-hour recall in patient-reported outcomes of an exploratory, phase 2b, randomized, double-blind, placebo-controlled clinical trial of sildenafil cream, 3.6% for the treatment of female sexual arousal disorder.”

Sabrina Martucci Johnson, President and CEO of Daré Bioscience, expressed satisfaction with the study results, emphasizing the consistency in patient-reported outcomes regardless of the recall period. This consistency offers flexibility on how to clinically measure the efficacy of Sildenafil Cream for FSAD patients. Dr. Annie Thurman, Medical Director at Daré Bioscience, noted the importance of being able to collect accurate data in a manner that is manageable for patients, given the condition's often dismissed and stigmatized nature.

The Phase 2b RESPOND study aimed to identify the patient group that benefited most significantly from Sildenafil Cream and determine the PRO measures that best reflect this improvement. The patient population and endpoints proposed to the U.S. Food and Drug Administration (FDA) for Phase 3 clinical development were chosen based on post-hoc analyses of the Phase 2b study data, which showed statistically significant and meaningful patient improvement.

Previously, Daré announced a positive end-of-Phase 2 meeting with the FDA, supporting the advancement of Sildenafil Cream for FSAD treatment. The company continues to work with the FDA on the development program for this treatment. Efficacy data from the Phase 2b RESPOND study were also published in Obstetrics & Gynecology, the official publication of the American College of Obstetricians and Gynecologists. This study, titled “Preliminary Efficacy of Topical Sildenafil Cream for the Treatment of Female Sexual Arousal Disorder: A Randomized Controlled Trial,” is available in the August 2024 issue.

FSAD, as described in the DSM-IV, is characterized by a persistent or recurrent inability to attain or maintain adequate genital arousal during sexual activity, often leading to distress or interpersonal difficulties. It is clinically similar to erectile dysfunction (ED) in men and is associated with insufficient blood flow to the genitalia. Sildenafil, the active ingredient in Viagra® for ED in men, is a phosphodiesterase-5 (PDE-5) inhibitor. Sildenafil Cream is a topical formulation of sildenafil designed to increase genital blood flow and enhance the female genital arousal response without the systemic side effects seen with oral sildenafil.

Market research indicates that approximately 16% of women in the U.S. aged 21 to 60, or around 10 million women, experience symptoms associated with FSAD and are seeking solutions to improve their condition. In contrast, the prevalence of complete ED in men is about 5% at age 40, increasing to approximately 15% at age 70.

Daré Bioscience is a biopharmaceutical company focused on developing innovative products for women's health. Their mission is to bring a diverse portfolio of differentiated therapies to market, primarily addressing contraception, vaginal health, reproductive health, menopause, sexual health, and fertility. Their portfolio includes XACIATO™ (clindamycin phosphate) vaginal gel 2%, approved for the treatment of bacterial vaginosis, Ovaprene®, a hormone-free monthly intravaginal contraceptive, and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for menopausal hormone therapy.

Daré Bioscience has received recognition for its contributions to women's health, with leadership named on the Medicine Maker’s Power List and Endpoints News’ Women in Biopharma 2022. In 2023, their CEO was honored as one of Fierce Pharma’s Most Influential People in Biopharma. The company also ranked #1 in the Small Company category of the San Diego Business Journal’s 2023 Best Places to Work Awards.