Palatin Technologies Reports Positive Phase 2B Results for Bremelanotide in Female Sexual Dysfunction Trial

Palatin Technologies

today reported positive top-line results, including the successful achievement of statistical significance for the primary endpoint and key secondary endpoints in its Phase 2B clinical trial evaluating the efficacy and safety of bremelanotide for the treatment of female sexual dysfunction (FSD). The data demonstrate that women taking bremelanotide showed statistically significant increases in the number of Satisfying Sexual Events (SSEs) and also showed statistically significant improved measures of overall sexual functioning and distress related to sexual dysfunction, compared with placebo. The primary endpoint data analysis of 327 pre-menopausal women with female sexual arousal disorder (FSAD), hypoactive sexual desire disorder (HSDD), or a combination of both disorders, the most common types of FSD, shows a clinically meaningful and statistically significant improvement (p=0.018) in the number of SSEs in women taking bremelanotide doses (mean change from 1.6 at baseline increasing to 2.4; pooled 1.25 mg and 1.75 mg doses) versus placebo (mean change from 1.7 at baseline increasing to 1.9) over the study period, resulting in a 50%