Daré Bioscience Announces Availability of Publication on the Patient-Centered Concept Elicitation Study for Female Sexual Arousal Disorder in The Journal of Sexual Medicine
The Concept Elicitation Study Informed the Selection of the Primary, Secondary, and Exploratory Endpoints Included in the Phase 2b RESPOND Clinical Study Evaluating the Efficacy and Safety of Sildenafil Cream, 3.6% in Premenopausal Patients with Female Sexual Arousal Disorder
Topline Data from the Exploratory Phase 2b RESPOND Study are Anticipated 2Q-2023
The concept elicitation study, also referred to as a content validity study, to explore the experience of condition-associated symptoms and the relative importance of FSAD symptoms, including their severity, bother, and impact, on participants’ health-related quality of life in pre- and postmenopausal women with FSAD was completed prior to commencement of the exploratory Phase 2b RESPOND clinical study of Sildenafil Cream, topline data for which are anticipated during 2Q-2023. The non-interventional study was conducted to identify and document the genital arousal symptoms that are the most problematic and most important symptoms to treat for women with FSAD. The findings of this content validity study helped facilitate alignment with the FDA on acceptable efficacy endpoints for the exploratory Phase 2b RESPOND study and future Phase 3 program, including a number of exploratory endpoints informed by the findings of the content validity study.
The content validity study included in-depth, qualitative, semi-structured concept elicitation interviews with premenopausal (n=23) and postmenopausal (n=13) women who were clinically diagnosed with FSAD by a trained sexual medicine clinician. The qualitative data from the interviews revealed a substantial physical and emotional burden of FSAD. The symptoms and impacts of this condition underscore the need for FDA-approved treatment options for pre- and postmenopausal women with FSAD. Results from this study also suggest that the manifestation and experience of FSAD are similar in pre- and postmenopausal women and that the unmet need for an FSAD treatment in the postmenopausal population is just as great as that of the premenopausal population.
The abstract of the journal article is available online: https://pubmed.ncbi.nlm.nih.gov/36763961/
“This peer-reviewed article, published in
FSAD 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 distinct from hypoactive sexual desire disorder (HSDD) in women, which is characterized primarily by a lack of sexual desire. 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.
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 topical cream formulation of sildenafil specifically designed to increase blood flow to the genital tissue in women. If development is successful, Sildenafil Cream has the potential to be the first FDA-approved treatment for FSAD.
Sildenafil Cream is designed to be applied locally to the vaginal tissue prior to sexual activity to facilitate vasodilation and increased blood flow directly to the genital tissue to improve the physical arousal response symptoms commonly associated with FSAD while avoiding systemic side effects observed with oral formulations of PDE-5 inhibitors.
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About Daré Bioscience
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. XACIATO is a clear, colorless, viscous gel, to be administered once intravaginally as a single dose. Daré’s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene®, a novel, hormone-free monthly intravaginal contraceptive whose
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Daré cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “objective,” or the negative version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to the timing of announcement of topline data from the Phase 2b RESPOND study of Sildenafil Cream, the importance of the content validity study, Sildenafil Cream’s potential as a safe and effective therapy for FSAD, Sildenafil Cream’s potential to be the first FDA-approved treatment for FSAD, and the market potential of Sildenafil Cream. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Daré’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, without limitation, risk and uncertainties related to: Daré’s ability to raise additional capital when and as needed to advance its product candidates, execute its business strategy and continue as a going concern; Daré’s ability to develop, obtain FDA or foreign regulatory approval for, and commercialize its product candidates and to do so on communicated timelines; failure or delay in starting, conducting and completing clinical trials of a product candidate; Daré’s ability to design and conduct successful clinical trials, to enroll a sufficient number of patients, to meet established clinical endpoints, to avoid undesirable side effects and other safety concerns, and to demonstrate sufficient safety and efficacy of its product candidates; Daré’s dependence on third parties to conduct clinical trials and manufacture and supply clinical trial material and commercial product; the risk that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; the risk that development of a product candidate requires more clinical or nonclinical studies than Daré anticipates; the loss of, or inability to attract, key personnel; the effects of the COVID-19 pandemic, macroeconomic conditions and geopolitical events on Daré’s operations, financial results and condition, and ability to achieve current plans and objectives, including the potential impact of the pandemic on Daré’s ability to timely commence, enroll, conduct and report results of its clinical trials and on the ability of third parties on which Daré relies to assist in the conduct of its business to fulfill their contractual obligations to Daré; the impact of pharmaceutical industry regulation and health care legislation in
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