On August 29, Daré Bioscience announced that the interim analysis of its Phase IIb Respond study of sildenafil cream in the treatment of female sexual arousal disorder (FSAD) has been positive, and it plans to complete all patient enrollment in Q4 2022 and Q2 2023. Report key results. However, the company did not release specific figures for the interim analysis.
The Respond study is a multicenter, double-blind, placebo-controlled Phase IIb clinical trial, planned to enroll 150 patients, to evaluate the efficacy and safety of sildenafil cream in female patients with FSAD. In addition, as there is currently no FDA-approved therapy for FSAD, the Phase III pivotal study has no reference efficacy endpoints. Therefore, the study was also designed to assess the sensitivity of multiple indicators as efficacy endpoints. The primary endpoint of the study was a composite of improved genital arousal and reduced distress associated with FSAD as assessed by the Patient Self-Assessment Scale (PRO).
Many women have sexual dysfunction due to the influence of traditional culture. However, because the performance of female sexual dysfunction is not as obvious as that of men, and the society does not pay much attention to it, a large number of women have the disease without knowing it.
According to reports, the incidence of sexual dysfunction in American women is about 43%. FSAD is a type of female sexual dysfunction, which is different from female hyposexuality disorder (HSDD). FSAD refers to the persistent or repeated inability to achieve or maintain an adequate physical response to sexual stimulation during sexual activity, similar to erectile dysfunction (ED) in men, while HSDD is characterized by a lack of libido. Like male ED, FSAD is associated with insufficient blood flow to the genitals.
Sildenafil, a phosphodiesterase 5 (PDE5) inhibitor developed by Pfizer, was approved in March 1998 for the treatment of pulmonary arterial hypertension. In August 2002, it was approved in China for the treatment of male erectile dysfunction under the trade name Viagra. Sildenafil cream (SST-6006) is a topical formulation developed by Strategic Science & Technologies (SST) as the preferred treatment for FSAD. In February 2018, Daré Bioscience entered into a licensing agreement with SST for the global development rights to sildenafil cream.
Unlike oral formulations of sildenafil, sildenafil cream is applied topically to vaginal tissue prior to sexual activity to promote vasodilation and increase genital blood flow, thereby improving symptoms of genital arousal associated with FSAD and Improves sexual experience while also avoiding the systemic side effects of oral formulations.
At present, there are 5 products under research in the world for the treatment of FSAD, among which CP-866087 developed by Pfizer and sildenafil cream developed by Daré Bioscience have made the fastest progress, and both have entered the phase II clinical stage.
The efficacy of sildenafil cream has been evaluated in Phase I and Phase IIa studies. The results of the phase I study (n=20) showed that sildenafil cream has good safety and tolerability at clinically relevant doses, and has the advantages of ease of use and easy absorption. Phase IIa study (n=30) showed that sildenafil cream increased blood flow to genital tissues compared to placebo. In addition, data from a thermography study (n=6) showed that genital temperature was significantly increased within 30 minutes of patients using sildenafil cream, suggesting that sildenafil cream has a positive effect on increasing genital blood flow.
Sabrina Martucci Johnson, President and CEO of Daré Bioscience, said: “We are pleased that this study reached an important milestone this year and look forward to evaluating key data next year. The FDA has developed, evaluated and approved a number of drugs for the treatment of ED in men. , but there is currently no drug approved to treat FSAD in women. If this phase IIb study can be completed, it will reach another important milestone, that is, sildenafil cream has the potential to become the first FDA-approved treatment for FSAD. Drugs. Based on the relative efficacy data from the interim analysis, we are satisfied that 150 female patients were enrolled and completed the study and believe that these Phase IIb data will facilitate our discussions with the FDA regarding pivotal registration plans and future approvals consistency.”