Phase 2B Clinical Trial Results
In the Phase 2B clinical trial, Vyleesi™ 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 female sexual dysfunction (FSD).
Efficacy was seen in both women with hypoactive sexual desire disorder (HSDD) and HSDD combined with Female Sexual Arousal Disorder (FSAD).
Vyleesi vs. 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.
Using the Female Sexual Function Index, or FSFI, the p-value for the 1.75 mg dose was less than 0.001 (depicted by **). The FSFI is a 19-item questionnaire measuring improvement in arousal, desire and overall sexual function.
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
A significantly higher percentage of women receiving the 1.75 mg Vyleesi dose – 55% – achieved a clinically meaningful change from baseline of at least one satisfying sexual event, compared to 37% of women receiving placebo. In addition, compared against placebo a significantly higher percentage of women also achieved a clinically meaningful improvement in sexual function, as measured by the FSFI (53% vs. 29%), and a clinically meaningful decrease in distress associated with sexual dysfunction as measured by the FSDS-DAO (69% vs. 45%).
Vyleesi was well-tolerated during the trial. The most common types of treatment-emergent adverse events reported more frequently in the Vyleesi arms were facial flushing, nausea and emesis, which were mainly mild-to-moderate in severity. The study dosed 394 patients. A total of 26 patients discontinued based on predefined blood pressure criteria; these patients were evenly distributed across the placebo and Vyleesi dosing arms. An additional 12 patients discontinued from the study due to adverse events (placebo 2, Vyleesi 10). Adverse events that most commonly led to discontinuation were nausea and emesis. No serious adverse events were attributed to Vyleesi during the trial.
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.