Phase III trial of bremelanotide in hypoactive sexual desire disorder meets primary endpoints-Palatin Technologies
Palatin Technologies has announced positive, statistically significant top-line results from the Reconnect Studies, its Phase III clinical trial program of lead drug candidate bremelanotide. The Reconnect Studies, investigating bremelanotide as an on-demand treatment for premenopausal women diagnosed with hypoactive sexual desire disorder ("HSDD"), met the pre-specified co-primary efficacy endpoints in both Phase III clinical trials.
In the preliminary review of the overall safety population (1,247 patients), bremelanotide appeared to be well tolerated. The most frequent adverse event was nausea, which was generally mild in nature. The safety profile of bremelanotide was consistent with prior clinical experience, and no new or unusual safety issues were identified. Palatin expects to present additional results from the Reconnect Studies at future sexual medicine and women's health conferences and in peer reviewed journal publications.