CRANBURY, N.J., Aug. 12 /PRNewswire-FirstCall/ -- Palatin Technologies, Inc. (NYSE Amex: PTN) today announced the completion of a Phase 1 clinical trial of subcutaneously administered bremelanotide, its melanocortin agonist drug candidate for treatment of male erectile dysfunction (ED) and female sexual dysfunction (FSD). The results demonstrate that with subcutaneous administration consistent therapeutic blood plasma levels can be obtained without blood pressure side effects. Based on the positive results of this study, Palatin has scheduled a meeting with the U.S. Food and Drug Administration to discuss initiation of a Phase 2B study of subcutaneously administered bremelanotide for ED.
"This study supports our hypothesis that increases in blood pressure and gastrointestinal events seen with intranasally administered bremelanotide were primarily related to high plasma levels in a subset of patients. We believe this was due to variability in drug uptake with intranasal administration," said Trevor Hallam, Ph.D., Executive Vice President of Research and Development of Palatin. "The switch from intranasal to subcutaneous administration appears to address the blood pressure concerns raised by the FDA. Our next step is to put this data in front of the FDA as we prepare to move bremelanotide back into a Phase 2 study later this year."
In all subjects, subcutaneous administration of bremelanotide resulted in consistent and predictable plasma concentrations at levels known from previous studies to improve erectile function. Other key results include:
|SOURCE Palatin Technologies, Inc.|
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