Data analysis of the individual 0.75 mg, 1.25 mg and 1.75 mg bremelanotide doses each showed clinically meaningful improvement for the primary endpoint and key secondary endpoints, with the 1.75 mg dose achieving statistical significance for the endpoints cited above.
Jeff Edelson, M.D., Chief Medical Officer for Palatin stated, "These data provide an important demonstration of the safety and efficacy of bremelanotide and suggest its potential utility for the treatment of FSD in premenopausal women. Moreover, the trial provides important data that will be instrumental in planning Phase 3 clinical trials and activities. We look forward to working closely with our expert advisors, and the FDA, to identify next steps in the late stage clinical development of this exciting drug."
"These safety and efficacy trial results are very encouraging and clearly warrant further clinical testing of bremelanotide in this patient population. Despite the pressing need for such treatments, there are presently no FDA approved therapies for the treatment of female sexual disorders, conditions with major negative health impacts on patients," said Sheryl Kingsberg, Ph.D., Division Chief, OB/GYN Behavioral Medicine, UH Case Medical Center, and a clinical investigator on the study.
Bremelanotide was well-tolerated during the trial. The most common types of treatment-emergent adverse events reported more frequently in the bremelanotide arms were facial flushing, nausea and emesis, which were mainly mild-to-moderate in severity. The study dosed 395 patients. A total of 26 patients discontinued from the study based on predefined blood pressure criteria: these patients were evenly distributed across the placebo and bremelanotide dosing arms. An additional 12 patients discontinued from the study due to adverse events (N=12, Placebo: 2, bremelanotide arms 0.75 mg: 0, 1.25 mg: 4, 1.75 mg: 6). Adverse events that most commonly led to discontinuation were nausea and emesis.The study was supervised by an independent Data Safety Monitoring Board. No serious adverse events were attributed to bremelanotide during the trial.