Dare announces initiation of subject enrollment in Phase 1 thermography study

Dare Bioscience announced initiation of screening and enrollment for a Phase 1 clinical study using thermography to assess the pharmacodynamic and pharmacokinetic characterization of Sildenafil Cream, 3.6%, a late-stage product candidate being developed as a potential new treatment for female sexual arousal disorder, FSAD. The quantitative pharmacokinetic and pharmacodynamic temperature data captured in a clinic setting in the study are expected to complement the patient reported outcome data collected in the ongoing Phase 2b RESPOND study, where the women use Sildenafil Cream in their home setting. During the thermography study, vulvar temperature, a surrogate for vulvar blood flow, will be recorded by thermography in a clinic setting. Increasing blood flow to the genital tissue, as Sildenafil Cream is designed to do, has the potential to improve genital arousal response and overall sexual experience for women. Unlike the oral formulations of PDE-5 inhibitors, Sildenafil Cream is designed to be applied locally to the vaginal tissue prior to sexual activity to facilitate vasodilation and increase blood flow directly to the genital tissue to improve the physical arousal response to address the lack of those genital arousal sensations commonly associated with FSAD. "We are excited to announce that enrollment is underway in this important supplemental thermography study," said Sabrina Martucci Johnson, President & CEO of Dare Bioscience. "This study has the potential to provide additional quantitative data regarding the ability of our cream formulation of the active ingredient sildenafil to increase genital blood flow, as assessed by vulvar temperature. These data are expected to complement forthcoming clinical findings from our Phase 2b RESPOND trial in preparation for a Phase 3 program."