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Bremelanotide, an investigational product candidate, is being developed for the treatment of hypoactive sexual desire disorder (HSDD) in pre-menopausal women. The PDUFA date for bremelanotide is June 23, 2019.  Bremelanotide is designed to be used in anticipation of a sexual encounter, and is thought to possess a novel mechanism of action that impacts the excitatory neural pathways in the brain to restore sexual desire.


Bremelanotide has been studied in more than 30 clinical trials with over 2,500 women. AMAG’s New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) was supported by clinical data from two identical large double-blind placebo-controlled Phase 3 studies in which bremelanotide met the pre-specified co-primary efficacy endpoints of improvement in desire and decrease in distress associated with low sexual desire as measured by validated patient-reported outcomes. Women in the trials had the option, after completion of the trial, to continue in an open-label safety extension study for an additional 12 months. Nearly 80% of patients elected to remain in the open-label portion of the study, and all of these patients received bremelanotide.


The most common adverse events were nausea, flushing, injection site reactions and headache. The majority of events were reported to be transient and mild-to-moderate in intensity.


AMAG PHARMACEUTICALS PRESENTS NEW DATA AT  THE AMERICAN COLLEGE OF OBSTETRICIANS AND GYNECOLOGISTS ANNUAL MEETING – AMAG Pharmaceuticals


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