Dare Bioscience (DARE) Announces Initiation of Phase 2b RESPOND Study of Sildenafil Cream, 3.6% in Women with Female Sexual Arousal Disorder

Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, and Strategic Science & Technologies, LLC (SST), a Cambridge, MA based novel topical drug delivery company, today announced the initiation of the Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6% for the treatment of female sexual arousal disorder (FSAD).

Sildenafil Cream is a proprietary topical formulation of sildenafil, a phosphodiesterase-5 (PDE-5) inhibitor, being developed as a first-in-category option for the treatment of FSAD. FSAD is the inability to reach or maintain a sufficient physical response to sexual stimulation and, of the various types of female sexual dysfunction disorders, FSAD is most analogous to erectile dysfunction (ED) in men. Sildenafil is the active ingredient in a tablet for oral administration currently marketed under the brand name Viagra® for the treatment of erectile dysfunction in men.

Unlike the oral formulations of PDE-5 inhibitors, Sildenafil Cream is applied locally to the vaginal tissue and is designed to facilitate vasodilation and increased blood flow directly to the genital tissue to improve the physical arousal response symptoms commonly associated with FSAD. If clinical development is successful, Sildenafil Cream has the potential to be the first FDA-approved FSAD treatment option.

The Phase 2b RESPOND study will evaluate Sildenafil Cream compared to placebo cream in pre- and peri-menopausal women over 12 weeks of at-home use following both a non-drug and placebo run-in period. Patient reported outcome (PRO) instruments will be used to screen eligible women with FSAD and to measure achievement of the primary efficacy endpoint, namely improvement in localized genital sensations of arousal and reduction in the distress that women with FSAD experience.

“We are honored to commence the Phase 2b study of Sildenafil Cream. Commencing the study now positions us for a potential topline data readout by the end of 2021, and over the next several months we will provide updates on our progress toward that target. Women have suffered far too long without a viable intervention to address FSAD and we believe Sildenafil Cream has the potential to be the first prescription product for this condition,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “This study is a significant milestone for Daré and our partner SST as we seek to bring to market a product that could address an important unmet need for women. The FSAD market is estimated to be as significant, if not more so, as the erectile dysfunction market in both the U.S. and the rest of the world.”

Market research suggests that 16% of women in the U.S. ages 21 to 60, or approximately 10 million women, are distressed from experiencing symptoms of low or no sexual arousal and seeking a solution to improve their condition. To put the market opportunity for an FDA-approved FSAD treatment in context, the prevalence of complete ED in men is estimated to be about 5% of men at age 40, increasing to about 15% at age 70.

“This is an important milestone in the field of female sexual dysfunction,” said Dr. Andrew Goldstein, Medical Advisor of Daré Bioscience and Past President of The International Society for the Study of Women's Sexual Health, as well as co-editor of the Textbook of Female Sexual Function and Dysfunction: Diagnosis and Treatment. “It is exciting to be working at the cutting edge of research focused on women’s sexual health and to advance a potential first-in-category treatment option for women suffering with FSAD.”

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