Palatin Technologies (Palatin) has completed phase 1 clinical trial of bremelanotide, its melanocortin agonist drug candidate for treatment of male erectile dysfunction (ED) and female sexual dysfunction (FSD).
The results showed that with subcutaneous administration, consistent therapeutic blood plasma levels can be obtained without blood pressure side effects.
In all subjects, subcutaneous administration of bremelanotide resulted in consistent and predictable plasma concentrations at levels known from previous studies, to improve erectile function.
The two week randomized, double-blind, placebo-controlled phase 1 study in 54 subjects (27 bremelanotide, 27 placebo) measured blood pressure at baseline, before and after each of 45 doses of bremelanotide or placebo administered subcutaneously.
The dose administered was selected to result in a plasma level of bremelanotide known, from previous studies, to be efficacious for improving erectile function. Continuous ambulatory blood pressure data was also collected for the first 48 hours after the initial dose in all subjects.
Based on the positive results of this study, Palatin has scheduled a meeting with the FDA to discuss initiation of a phase 2B study of subcutaneously administered bremelanotide for ED.