(122) POSITIVE EFFECTS OF BREMELANOTIDE ON FEMALE SEXUAL AROUSAL AND ORGASM IN PREMENOPAUSAL WOMEN WITH HSDD: FSFI DATA FROM THE RECONNECT TRIALS

Abstract Introduction Bremelanotide is a melanocortin receptor agonist approved by the FDA as an as-needed treatment for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. In phase 3 clinical trials, bremelanotide treatment resulted in a statistically significant increase in the mean sexual desire domain score of the Female Sexual Function Index (FSFI) compared to the placebo group and significantly decreased distress associated with low sexual desire. However, the effects of bremelanotide on sexual function have not been completely characterized. Objective To assess the effects of bremelanotide over time on arousal and orgasmic function in premenopausal women diagnosed with HSDD. Methods Two randomized, placebo-controlled, multi-institutional phase 3 clinical trials (RECONNECT) were conducted in premenopausal women diagnosed with acquired, generalized HSDD. Study participants were randomized to either placebo or bremelanotide (1.75 mg/0.3 mL subcutaneous injection; Vyleesi®) and were instructed to dose approximately 45 minutes before sexual activity. Previously unreported data on arousal and orgasm domain scores of the FSFI were analyzed by monthly assessments from baseline to the end of trial at 24 weeks. Investigators at study sites obtained approval for this trial from local institutional review boards in the US or from independent ethics committees in Canada. All study participants provided informed consent. All data were expressed as change from baseline and differences between bremelanotide and placebo at each assessment time were analyzed by Krusal-Wallis test using SAS version 9.3. Results Baseline FSFI arousal domain scores ranged from 2.61 to 2.64 in the bremelanotide group and 2.56 to 2.57 in the placebo group. Baseline FSFI orgasm domain scores ranged from 2.93 to 3.11 in the bremelanotide group and 2.94 to 3.03 in the placebo group. In both studies, at the first post-dosing assessment at 4 weeks, FSFI arousal and FSFI orgasm domain scores were significantly higher in the bremelanotide group (23-25% and 16-21% increase over baseline for arousal and orgasm, respectively) than the placebo group (5-10% and 0-9 % increase over baseline for arousal and orgasm, respectively). Arousal and orgasm domain scores for the bremelanotide group remained significantly higher than placebo throughout the study and continuously increased to the end of the study at 24 weeks. In contrast, study participants treated with placebo experienced a smaller increase in arousal and orgasm domain scores, which plateaued and subsequently declined between weeks 16 and 20. Conclusions Bremelanotide, dosed as needed approximately 45 minutes before sexual activity, facilitated sexual arousal and orgasm in premenopausal women diagnosed with HSDD. Improvements occurred within the first month of dosing and continued to increase over 24 weeks. These findings underscore the interdependence of various aspects of sexual function and demonstrate that treating HSDD can improve other aspects of the sexual response. Disclosure Yes, this is sponsored by industry/sponsor: Cosette Pharmaceuticals, Palatin. Clarification: Industry initiated, executed and funded study. Any of the authors act as a consultant, employee or shareholder of an industry for: Cosette Pharmaceuticals.