Two randomized phase 3 trials of safety and efficacy of bremelanotide 1.75 mg have found that the drug significantly improved sexual desire and related distress in premenopausal women with hypoactive sexual desire disorder (HSDD). The two separate identically designed studies were conducted as per the recommendation of the US Food and Drug Administration (FDA) following the success of a phase 2b study. The results were published in Obstetrics & Gynecology.
In case you missed it: Sexual Dysfunction Treatment Approved By FDA
The randomized, double-blind, placebo-controlled, multicenter clinical trials (RECONNECT) evaluated the safety and efficacy of subcutaneously administered bremelanotide. Patients were randomized 1:1 to receive either 24 weeks of treatment or placebo. Patients were observed while self-administering an in-clinic dose, and blood pressure (BP) measurements were taken at up to an hour predose and 1.0, 1.5, and 2.0 hours postdose.
Participants could self-administer a maximum of 12 doses of bremelanotide as needed (approximately 45 minutes before anticipated sexual activity) as outpatients, but no more than one dose per 24-hour period. Coprimary endpoints of the study were change from baseline to end-of-study in the Female Sexual Function Index-desire domain (FSFI-D) score and Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) item 13.
The two studies (NCT02333071 [study 301] and NCT02338960 [study 302]) recruited health, premenopausal women aged 18 years or older in stable monogamous relationships with a partner. Diagnosis of HSDD was performed using the Diagnostic Screening Guide for HSDD and was completed by the investigator. All patients had a diagnosis of acquired, generalized HSDD, with or without decreased arousal, for 6 months or more; had prior experience of normal sexual function (self-defined) for 2 years or more; and were willing to engage in sexual activities one or more time per month during the study.