Palatin and King are jointly developing the drug for the treatment of both male and female sexual dysfunction. The primary objective of these two dose-ranging clinical trials is to identify safe and efficacious doses for evaluation in phase III pivotal trials slated to begin in the first quarter of 2007.
The mechanism of action of bremelanotide, a melanocortin agonist, may offer important benefits over currently available products for the treatment of erectile dysfunction (ED) because it acts on the pathway that controls sexual function without acting directly on the vascular system.
“Together with our colleagues at King, we are very pleased to achieve this significant milestone for these two critically important clinical trials. The data from these two studies should allow the companies to develop a robust phase III pivotal trial program for consideration by the FDA,” said Dr Trevor Hallam, executive vice president, R&D of Palatin.