On Wednesday, DARÉ Bioscience, a California-based biopharmaceutical company, announced the initiation of Phase 2 clinical trials of Sildenafil Cream for the treatment of female sexual arousal disorder (FSAD).
Sildenafil Cream is a topical formulation that contains sildenafil citrate, a phosphodiesterase-5 (PDE-5) inhibitor, which is predominately used for the treatment of erectile dysfunction (ED) in men. Sold under the brand name Viagra, sildenafil citrate has been used widely to boost erections in men.
Sildenafil Cream is being developed as a first-in-category option for the treatment of FSAD. FSAD is the inability to get aroused during sexual stimulation, which is often associated with low libido, painful coition, and difficulty achieving orgasm.
Unlike Viagra that is taken orally, Sildenafil Cream is applied locally to the vaginal tissue. The cream is designed to facilitate vasodilation and increase blood flow directly to the genitals to improve the arousal response in women.
The Phase 2 trial will evaluate the efficacy of Sildenafil Cream in pre- and peri-menopausal women.
Sabrina Martucci Johnson, President and CEO of Daré Bioscience, said, “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,” she added. “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,” Johnson explained.
Dr. Andrew Goldstein, Medical Advisor of Daré Bioscience, said, “This is an important milestone in the field of female sexual dysfunction. 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.”
Daré Bioscience is a biopharmaceutical company committed to the advancement of innovative products for women’s health issues. The article appeared on BioSpace.