Bremelanotide: Phase IIb data

Top-line data from a double-blind, North American Phase IIb trial in 327 evaluable premenopausal women with FSD showed that subcutaneous bremelanotide met the primary endpoint of increasing the mean number of satisfying sexual events from baseline to week 16 vs. placebo (0.8 vs. 0.2 events, p=0.018). Bremelanotide also met the secondary endpoints of improving mean FSFI total score (3.55 vs.1.88 points, p=0.0017) and FSDS total score in the arousal domain (11.1 vs. 6.8 points, p=0.036) vs. placebo. Palatin said that for all endpoints, the pre-specified statistical analysis agreed upon with FDA was to compare pooled data for the 1.25 and 1.75 mg doses of bremelanotide to placebo. ...