Bremelanotide for Female Sexual Dysfunctions: Responder Analyses From a Phase 2B Dose-Ranging Study.

INTRODUCTION: Bremelanotide is a novel heptapeptide melanocortin receptor-4 agonist. This study examined its at-home, as-needed subcutaneous self-administration by premenopausal women with female sexual dysfunctions. Key outcomes were subjected to prespecified responder analyses.

METHODS: After 4 weeks of at-home placebo self-dosing (baseline period), premenopausal women with hypoactive sexual desire disorder, female sexual arousal disorder, or both were randomized to 12-week, at-home use of placebo or bremelanotide at 0.75, 1.25, or 1.75 mg. End points included changes from baseline to end of study in the monthly number of satisfying sexual events and in Female Sexual Function Index total score and Female Sexual Distress Scale-Desire/Arousal/Orgasm total score. Analyses of percent of responders were anchored to expert estimates of minimal clinically important differences: +1 for satisfying sexual events, +2.1 for Female Sexual Function Index, and -7 for Female Sexual Distress Scale-Desire/Arousal/Orgasm.

RESULTS: Overall, 327 randomized participants used at-home study drug and provided data (for satisfying sexual events, 324). For placebo and bremelanotide at 0.75 mg, 1.25 mg, 1.75 mg, and 1.25 and 1.75 mg pooled, responder rates were 37%, 38%, 48%, 55%, and 51% for satisfying sexual events; 46%, 45%, 61%, 69%, and 65% on the Female Sexual Function Index; and 45%, 49%, 60%, 69%, and 64% on the Female Sexual Distress Scale-Desire/Arousal/Orgasm. For all three end points, the difference from placebo was statistically significant (P <.05, Cochran-Mantel-Haenszel test) at 1.75 mg and at 1.25 and 1.75 mg pooled.

CONCLUSIONS: Premenopausal women using self-administered subcutaneous bremelanotide for female sexual dysfunctions showed dose-dependent separations from placebo in the percentages of patients reaching expert-determined minimally clinically important differences for three clinically relevant variables with statistical significance compared with placebo for all three responder rates at 1.75 mg and 1.25 mg and 1.75 mg pooled.