Clinical Trial Results
In our recently completed Phase 2B clinical trial, bremelanotide at 1.25 mg and 1.75 mg doses significantly increased sexual arousal, sexual desire and the number of sexually satisfying events, and decreased associated distress in premenopausal women with FSD.
Efficacy was seen in both women with hypoactive sexual desire disorder (HSDD) and HSDD combined with Female Sexual Arousal Disorder.
Bremelanotide VS. Placebo
Bremelanotide showed a statistically significant increase in the number of satisfying sexual events (SSEs) against placebo.
The p-value for the 1.75 mg dose was less than 0.05. The other primary measures in the Phase 2B clinical trial were patient reported outcomes measured using validated questionnaires.
Female Sexual Distress Scale
In the trial we also measured the mean change from baseline in a validated measurement tool of distress related to sexual dysfunction, the Female Sexual Distress Scale-Desire/Arousal/Orgasm, or FSDS-DAO. For the p-value for the 1.75 mg dose was less than 0.001 (depicted by ***). The FSDS-DAO is a 15-item questionnaire that measures personal distress associated with FSD.
Reception and Adverse Events
We have extensive clinical experience with bremelanotide. Over 2,500 patients have received bremelanotide in 30 clinical studies with either intranasal or subcutaneous formulations, with demonstrated efficacy for both FSD and erectile dysfunction.
We have presented the results of our Phase 2B trial at national and international scientific meetings.