Daré Bioscience Announces Additional Positive Data from Exploratory Phase 2b RESPOND Study of Sildenafil Cream, 3.6% in Women

Daré Bioscience, Inc. and its collaborator Strategic Science & Technologies, LLC (SST) recently announced additional positive data from the exploratory Phase 2b RESPOND study evaluating topical Sildenafil Cream, 3.6% (Sildenafil Cream) as a treatment for female sexual arousal disorder (FSAD). Additional data reported today support continued clinical development of Sildenafil Cream to evaluate its potential to treat FSAD and/or female sexual interest/arousal disorder (FSIAD). Specifically, an exploratory endpoint regarding sexual desire demonstrated a statistically significant improvement from baseline to the 8-week mark after randomization in women in the intent to treat (ITT) population who used Sildenafil Cream compared to placebo, at P value = 0.022. The improvement in sexual desire at the 8-week mark compared to baseline in the Sildenafil Cream ITT group persisted through 12 weeks post-randomization (end of study).

“In this study, improvement was seen in arousal and orgasm, as well as sexual desire. Such changes are consistent with those seen in men treated for erectile dysfunction. Namely, improve one’s arousal, and ultimately orgasm, and desire increases as well. An FDA-approved option like this for women would provide improvements across the sexual experience continuum, as men have had for over 25 years,” said James A. Simon. MD, CCD, NCMP, IF, FACOG, Clinical Professor, Obstetrics and Gynecology, George Washington University and President and Medical Director of IntimMedicine Specialists, as well as Past President of The International Society for the Study of Women’s Sexual Health (ISSWSH), and Past President of The North American Menopause Society (NAMS).

Based on data from the exploratory Phase 2b RESPOND study, demonstrating improvement in multiple facets of female sexual dysfunction, and because there is no FDA-approved product for FSAD, as described in the fourth edition of the Diagnostic and Statistical Manual (DSM-IV), or for FSIAD, as described in the fifth edition of the Diagnostic and Statistical Manual (DSM-5), Sildenafil Cream has the potential to be a first-in-category product.

Sildenafil, a phosphodiesterase-5 (PDE-5) inhibitor, is the active ingredient in a tablet for oral administration currently marketed under the brand name Viagra for the treatment of ED in men. Sildenafil Cream is an investigational, proprietary cream formulation of sildenafil designed for topical administration to the vulvar-vaginal tissue on demand to increase genital blood flow and provide improvements in the female genital arousal response, while avoiding systemic side effects observed with oral formulations of sildenafil.

The previously announced positive topline data from the exploratory Phase 2b RESPOND study included findings that women treated with Sildenafil Cream had more satisfactory sexual events and experienced improvement in arousal lubrication and orgasm. As was the case with sexual desire, improvements in arousal lubrication and orgasm achieved maximum separation from placebo at the 8-week mark after randomization compared to baseline. These improvements in the Sildenafil Cream ITT group were maintained through the end of study assessment, demonstrating persistence while on treatment, whereas, in the placebo group, no such trends were observed, with no such improvements achieved at the 8-week mark. While a persistent response in arousal lubrication, orgasm and sexual desire was observed in the Sildenafil Cream ITT group through the end of study assessment, no endpoint achieved statistical significance at end of study. Daré intends to review the data with the FDA, including discussing the data from assessments as early as the 4- and 8-week mark after randomization where women randomized to Sildenafil Cream exhibited improvement.

FSAD, as described in the DSM-IV, is a condition characterized as primarily by a persistent or recurrent inability to attain or maintain sufficient genital arousal (an adequate lubrication-swelling response) during sexual activity, frequently resulting in distress or interpersonal difficulty, and, of the various types of female sexual dysfunction disorders, FSAD is most analogous to erectile dysfunction (ED) in men. As with ED in men, FSAD is associated with insufficient blood flow to the genitalia.

FSIAD is characterized in the DSM-5 as lack of, or significantly reduced, sexual interest and/or arousal for at least six months and the symptoms must be severe enough to cause clinically significant distress. A woman must have three of the following six symptoms in order to receive an FSIAD diagnosis: absent or reduced interest in sexual activity; absent or reduced sexual thoughts or fantasies; no or reduced initiation of sexual activity, and typically unreceptive to a partner’s attempts to initiate; absent or reduced sexual excitement or pleasure in almost all or all sexual encounters; absent or reduced sexual interest/arousal in response to any internal or external sexual cues; and absent or reduced genital or non-genital sensations during sexual activity in all or almost all sexual encounters. FSIAD can be lifelong or acquired, range from mild to severe, and may be generalized or situational.

Market research suggests that 16% of women in the US ages 21 to 60, or approximately 10 million women, are distressed from experiencing symptoms associated with FSAD, including lack of or low sexual arousal, and are actively seeking solutions to improve their condition. In comparison, 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.

Daré Bioscience is a biopharmaceutical company committed to advancing innovative products for women’s health. The company’s mission is to identify, develop and bring to market a diverse portfolio of differentiated therapies that prioritize women’s health and well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, vaginal health, reproductive health, menopause, sexual health and fertility.

Daré’s first FDA-approved product, XACIATO (clindamycin phosphate) vaginal gel, 2% is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older, which is under a global license agreement with Organon. Daré’s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene, a novel, hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil to treat female sexual arousal disorder utilizing the active ingredient in Viagra; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for menopausal hormone therapy. For more information, visit www.darebioscience.com.