Palatin Technologies announced that the New Drug Application (NDA) for bremelanotide has been submitted to the Food and Drug Administration (FDA) for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. 

Bremelanotide is thought to work by activating endogenous melanocortin pathways involved in sexual desire and response. If approved, bremelanotide would be the first pharmacologic therapy for premenopausal women with HSDD used only as needed prior to anticipated sexual activity. 

The NDA submission was supported by data from two double-blind, placebo-controlled, randomized parallel-group Phase 3 trials of bremelanotide involving over 1,200 patients. In the studies, patients were randomized 1:1 to either bremelanotide 1.75mg subcutaneous (SC) injection or placebo with a 24-week evaluation period. Both trials met the pre-specified endpoints of median improvement in desire and decrease in distress associated with low sexual desire as measured by validated patient-reported outcome instruments. 

After the trial ended, 80% of patients chose to continue in an open-label safety extension study for an additional 52 weeks. Mild-to-moderate nausea, flushing, and headache were the most commonly reported adverse events in the trials. 

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If the NDA is accepted, the FDA will set a goal Prescription Drug User Fee Act (PDUFA) date to complete its review of bremelanotide. AMAG Pharmaceuticals has been granted exclusive rights to develop and commercialize bremelanotide in North America. 

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