Bremelanotide for Hypoactive Sexual Desire Disorder: Age and Weight Subgroup Efficacy Analyses [1Q]

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Bremelanotide, an investigational new drug, is a melanocortin 4 receptor agonist that has demonstrated efficacy in the treatment of hypoactive sexual desire disorder (HSDD) in women. In this analysis, bremelanotide efficacy was investigated within age and weight subgroups.


Women from two phase 3 studies (RECONNECT) and one phase 2 study were separated into age and weight quartiles. After 4-week placebo run-in period, women self-administered 1.75 mg of bremelanotide via auto-injector pen, as desired, or equal volume placebo for 12 (phase 2) or 24 (phase 3) weeks. Efficacy was assessed using FSFI and FSDS-DAO scoring systems, with FSFI desire domain (FSFI-D) and FSDS-DAO distress resulting from low desire (Item 13) as RECONNECT co-primary endpoints.


For the total integrated population (N=1337), the difference in FSFI-D mean changes from baseline (bremelanotide-placebo) was 0.38. Differences in mean FSFI-D changes from baseline for each age quartile (n-value range: 150-187) were 0.21 (19-33 y), 0.39 (>33-39 y), 0.56 (>39-44 y), and 0.34 (>44-56 y). Differences in mean FSFI-D changes for each weight quartile (n-value range: 159-181) were 0.30 (39.8-63.1 kg), 0.42 (>63.1-73.5 kg), 0.43 (>73.5-87.6 kg), and 0.34 (>87.6-189.9 kg). Significantly greater (P<0.05) changes in FSFI-D were achieved with bremelanotide vs placebo across all age and weight quartiles. FSDS-DAO Item 13 was also significantly improved across age and weight quartiles with the exception of the 39.8-63.1 kg (P=0.05) weight quartile.


Bremelanotide demonstrated efficacy in women regardless of age. Bremelanotide significantly improved desire across weight quartiles and showed a trend in decreasing distress.

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