Palatin Technologies, Inc. (NYSE Amex: PTN) today announced positive results 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 sustained clinically significant blood pressure effects and support the continued development of bremelanotide.
As part of the analysis of the effects of bremelanotide on blood pressure, the Company engaged an independent panel of cardiovascular experts to evaluate both study results and an integrated cardiovascular safety analysis conducted on data from completed bremelanotide studies. Based on recommendations from the outside panel and its own internal review, Palatin intends to engage the Food and Drug Administration (FDA) in discussions regarding clinical trial designs to further study bremelanotide for the treatment of sexual dysfunction.
Palatin expects to meet with the FDA in the fourth quarter of calendar year 2010 to discuss initiation of a Phase 2 study of subcutaneously administered bremelanotide, as a monotherapy and as a combination therapy with a PDE-5 inhibitor such as sildenafil (Viagra®), for men with ED who are not responsive or inadequately responsive to PDE-5 inhibitor therapies alone.
The objective of the placebo-controlled, randomized, double-blind, cross over safety study was evaluation of blood pressure effects of subcutaneous bremelanotide in healthy male volunteers between 45 and 65 years old. The study also evaluated dose-to-dose consistency of plasma exposure of bremelanotide. A total of 49 subjects were dosed in the safety study; nineteen of the subjects were enrolled in a sub-study and completed a graded exercise treadmill test as a surrogate for the cardiovascular effects of sexual activity.
"The commercial opportunity of bremelanotide for sexual dysfunction is significant. About 35% of patients with ED do not respond to approved oral therapies, and with limited treatment options these patients are ideal candidates for subcutaneous bremelanotide," stated Carl Spana, Ph.D., President and CEO of Palatin. "Plus, we have an additional opportunity with female sexual dysfunction (FSD), which also represents a large market opportunity with no FDA approved drugs."
SOURCE Palatin Technologies, Inc.