006 Bremelanotide for Hypoactive Sexual Desire Disorder: Integrated Subgroup Analysis According to FSFI Total Score at Screening

Abstract

Bremelanotide (BMT) is a melanocortin receptor 4 agonist that is being investigated as a treatment for hypoactive sexual desire disorder (HSDD) in premenopausal women. Clinical studies indicate that BMT has greater efficacy than placebo for treatment of HSDD. The objective of this integrated analysis was to investigate BMT efficacy vs placebo for subjects according to pre-specified patient reported outcome (PRO) definitions of HSDD at baseline. The total integrated population (N=1341) consisted of premenopausal women from two phase 3 studies (RECONNECT) and one phase 2 study who were divided into subgroups according to FSFI total score (sum of multiple domains) at screening. The FSFI desire domain (FSFI-D) and FSDS-DAO distress resulting from low desire (Item 13) were PROs that served as co-primary endpoints of the phase 3 studies. For subjects belonging to the lowest quartile (Q1) of baseline FSFI total scores (<16.5), the mean (SD) changes in FSFI-D from baseline for the BMT- and placebo-treated groups were 0.64 (1.13) and 0.31 (0.96), respectively. For baseline FSFI total score quartiles 2 (Q2: 16.5-20.49), 3 (Q3: 20.5-25.49), and 4 (Q4: ≥25.5), mean changes in FSFI-D for BMT vs placebo were 0.64 (0.96) vs 0.19 (0.96), 0.54 (1.11) vs 0.12 (0.99), and 0.57 (0.77) vs 0.46 (1.02), respectively. In the total integrated population, the respective mean (SD) changes in FSFI-D from baseline for the BMT and placebo arms were 0.62 (1.07) and 0.24 (0.97). For analysis of FSDS-DAO Item 13, quartiles 1-3 demonstrated mean changes (SD) from baseline for BMT vs placebo of -0.8 (1.19) vs -0.4 (1.10), -0.7 (1.17) vs -0.4 (1.06), and -0.7 (1.11) vs -0.4 (1.09), respectively. There was no difference in mean change [SD] between the BMT (-0.6 [1.14]) and placebo (-0.6 [1.06]) groups among subjects in Q4. In the total integrated population, the respective mean (SD) changes in FSDS-DAO Item 13 for the BMT and placebo arms were -0.7 (1.17) and -0.4 (1.08). For both endpoints, the estimated differences between treatment groups were confirmed as statistically significant (p<0.01) for Q1, Q2, and Q3, but not Q4. No clinically significant differences in SSE mean change from baseline were observed in any quartile of FSFI total score at screening.