Palatin Technologies announced that its exclusive North American licensee for bremelanotide, AMAG Pharmaceuticals, has submitted a New Drug Application (NDA) to the FDA for Rekynda (bremelanotide) for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. If approved, bremelanotide would become the first and only as desired pharmacologic option in the U.S. indicated for the treatment of HSDD in premenopausal women. Palatin expects that within 60 days the FDA will determine whether the NDA is complete for filing.

Palatin previously announced positive results for two Phase III trials of bremelanotide for the treatment of HSDD in premenopausal women that met the pre-specified co-primary efficacy endpoints. The Phase III RECONNECT studies for HSDD in premenopausal women consisted of two double-blind placebo-controlled, randomized parallel group studies comparing the as desired use of 1.75 mg of bremelanotide versus placebo, in each case, delivered via a subcutaneous auto-injector. Each trial consisted of more than 600 patients randomized in a 1:1 ratio to either the treatment arm or placebo with a 24 week evaluation period. In both clinical trials, bremelanotide met the pre-specified co-primary efficacy endpoints of median improvement in desire and decrease in distress associated with low sexual desire as measured using validated patient-reported outcome instruments. Women in the trials had the option, after completion of the trial, to continue in an open-label safety extension study for an additional 52 weeks. Nearly 80% of patients who completed the randomized portion of the study elected to remain in the open-label portion of the study. In the Phase III clinical trials, the most frequent adverse events were nausea, flushing, and headache, which were generally mild-to-moderate in intensity and were transient. Source

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