ARTICLE | Clinical News

Bremelanotide: Phase I data

August 23, 2010 7:00 AM UTC

In a double-blind, placebo-controlled, crossover Phase I trial in 49 healthy male volunteers ages 45-65, subcutaneous bremelanotide achieved therapeutic blood plasma levels with no sustained clinically significant effects on blood pressure. Palatin plans to meet with FDA in 4Q10 to discuss a Phase II trial of subcutaneous bremelanotide as monotherapy and as a combination therapy with a phosphodiesterase-5 (PDE-5) inhibitor to treat men with ED who are not responsive or inadequately responsive to PDE-5 inhibitors alone. ...