{"id":795023,"date":"2024-12-16T08:07:06","date_gmt":"2024-12-16T13:07:06","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-announces-phase-3-plans-for-sildenafil-cream-3-6-in-the-treatment-of-female-sexual-arousal-disorder-fsad\/"},"modified":"2024-12-16T08:07:06","modified_gmt":"2024-12-16T13:07:06","slug":"dare-bioscience-announces-phase-3-plans-for-sildenafil-cream-3-6-in-the-treatment-of-female-sexual-arousal-disorder-fsad","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-announces-phase-3-plans-for-sildenafil-cream-3-6-in-the-treatment-of-female-sexual-arousal-disorder-fsad\/","title":{"rendered":"Dar\u00e9 Bioscience Announces Phase 3 Plans for Sildenafil Cream, 3.6%, in the Treatment of Female Sexual Arousal Disorder (FSAD)"},"content":{"rendered":"
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FSAD is clinically analogous to erectile dysfunction in men.
To date, there are no FDA-approved pharmacological treatments for FSAD; Dar\u00e9\u2019s Sildenafil Cream has the potential to receive the first FDA approval for FSAD.<\/p>\n

Market research estimates approximately 10 million women in the U.S. are distressed from experiencing symptoms associated with FSAD and are actively seeking solutions to improve their condition.<\/p>\n

SAN DIEGO, Dec. 16, 2024 (GLOBE NEWSWIRE) — Dare\u0301\u00a0Bioscience, Inc.\u00a0(NASDAQ: DARE), a leader in innovation for the health and wellbeing of women, and its collaborator\u00a0Strategic Science & Technologies, LLC\u00a0(SST), a\u00a0Cambridge, MA\u00a0based novel topical drug delivery company, today announced plans for a Phase 3 study of Sildenafil Cream, 3.6%, an investigational topical cream formulation of sildenafil being developed as an on-demand treatment for female sexual arousal disorder (FSAD), reflecting U.S. Food and Drug Administration (FDA) feedback for safety and efficacy evaluations to support the indication of treatment of FSAD in premenopausal women.<\/p>\n

\u201cWe have appreciated the FDA\u2019s collaboration on the Phase 3 design for this novel therapeutic indication for women,\u201d said Sabrina Martucci Johnson, President and CEO of Dar\u00e9 Bioscience. \u201cWhile increased attention has been focused on female sexual dysfunctions over the past several years, no pharmacologic options have yet been\u00a0FDA\u00a0approved for FSAD, a condition which significantly compromises a woman’s ability to have a pleasurable sexual experience. We are excited about the potential for Dar\u00e9\u2019s Sildenafil Cream formulation to address this critical unmet need in women’s sexual health, and that there is a clear path forward on how to evaluate the safety and efficacy of this novel formulation of the same active in Viagra\u00ae<\/sup> so that women may have access to a safe, effective and \u2018on demand\u2019 solution to difficulties with sexual arousal allowing for a more intense and enjoyable sexual experience.\u201d<\/p>\n

As an immediate next step, Dar\u00e9 will submit the protocol and statistical analysis plan for an adequate and well-controlled Phase 3 clinical study, reflecting the FDA\u2019s recommendations, to the FDA in the first quarter of 2025, and is targeting mid-2025 for commencement of the Phase 3 study.<\/p>\n

A second confirmatory Phase 3 study will be required to support the New Drug Application (NDA) submission.<\/p>\n

With Sildenafil Cream\u2019s potential to be the first\u00a0FDA-approved product for FSAD, Dar\u00e9 is poised to create a new market category within the female sexual dysfunction space.\u00a0<\/p>\n

\n About FSAD and Sildenafil Cream, 3.6%<\/strong>\n <\/p>\n

FSAD, as described in the DSM-IV, is a condition characterized 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. FSAD is clinically analogous to erectile dysfunction (ED) in men. As with ED in men, FSAD is associated with insufficient blood flow to the genitalia. To date, there are no FDA-approved pharmacological treatments for FSAD.<\/p>\n

Sildenafil, a phosphodiesterase-5 (PDE-5) inhibitor, is the active ingredient in a tablet for oral administration currently marketed under the brand name Viagra\u00ae<\/sup> for the treatment of ED in men. Sildenafil Cream, 3.6% (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.<\/p>\n

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 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.<\/p>\n

\n Completed Sildenafil Cream, 3.6% Exploratory Phase 2b RESPOND Study<\/strong>\n <\/p>\n

The exploratory Phase 2b RESPOND study was specifically designed to identify the patient population that experienced the most meaningful improvement from Sildenafil Cream and the questions to ask them, or the patient-reported outcome (PRO) measures, that best reflect that improvement, to inform Phase 3 design for this potential first-in-category treatment for FSAD. As previously announced, safety and efficacy data from the Phase 2b RESPOND study have been published in The Journal of Sexual Medicine<\/em> and Obstetrics & Gynecology<\/em>, respectively:<\/p>\n