Daré Bioscience Announces Phase 3 Plans for Sildenafil Cream Development to Address Female Sexual Arousal Disorder

Daré Bioscience, Inc., a company at the forefront of female health and wellness innovation, has recently disclosed its Phase 3 clinical development plans for Sildenafil Cream, 3.6%, intended for the treatment of Female Sexual Arousal Disorder (FSAD) in premenopausal women. This announcement follows constructive discussions with the U.S. Food and Drug Administration (FDA), setting the stage for important advancements in women’s healthcare.

Sildenafil Cream, a topical cream formula of sildenafil, is being developed as an on-demand therapy for FSAD, a condition that impacts a woman’s sexual experience. To date, there are no FDA-approved pharmacological treatments for FSAD, making this development a potential milestone in the field.

In a press release issued on December 16, 2024, Daré Bioscience communicated its intentions to submit the protocol and statistical analysis plan for a comprehensive Phase 3 clinical study of Sildenafil Cream in premenopausal women with FSAD. This submission is slated for the first quarter of 2025, with plans to initiate the Phase 3 study by mid-2025. Notably, a second confirmatory Phase 3 study will be necessary to support a New Drug Application (NDA) submission.

The Phase 3 study will replicate the 12-week double-blind treatment period structure from the Phase 2b RESPOND clinical study of Sildenafil Cream. It will assess the cream’s efficacy compared to a placebo cream and will include co-primary efficacy endpoints for arousal sensations and associated distress, aligning with the Phase 2b RESPOND study design.

Sildenafil, the active ingredient in Viagra®, has shown promise in tablet form for treating erectile dysfunction in men. Sildenafil Cream, 3.6%, is a distinctive cream formulation created for topical application to the vulvar-vaginal tissue, aiming to enhance genital blood flow and improve female genital arousal without the systemic side effects linked to oral sildenafil formulations.

Phases 2b RESPOND study results fortified the groundwork for this Phase 3 study. Daré Bioscience’s commitment to addressing unmet medical needs in women’s health extends beyond FSAD. The company’s diverse portfolio includes potential first-in-category candidates like Ovaprene® and DARE-HRT1, emphasizing Daré’s dedication to enhancing outcomes in contraception, sexual health, pelvic pain, fertility, infectious diseases, and menopause.

Forward-looking statements in this report highlight Daré’s optimism regarding the potential of Sildenafil Cream and its plans for continued clinical development, always taking into account regulatory guidelines and the evolving landscape of women’s healthcare advancements.

The article above is a summary derived from the 8-K SEC Filing of Daré Bioscience. For the complete text of the filing, please refer to the source documents.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Daré Bioscience’s 8K filing here.

About Daré Bioscience

Daré Bioscience, Inc, a biopharmaceutical company, identifies, develops, and markets products for women's health in the United States. It develops therapies in the areas of contraception, reproductive health, menopause, fertility, and sexual and vaginal health. The company offers XACIATO for the treatment of bacterial vaginosis in female patients 12 years of age and older.