Palatin Technologies, Inc. today announced the completion of first cohort dosing in a placebo-controlled, multiple dose study of bremelanotide, its experimental treatment for sexual dysfunction. The primary endpoint in this double-blind safety study is evaluation of blood pressure effects of subcutaneous bremelanotide in men between 45 and 65 years old. The study will also evaluate consistency of plasma exposure of bremelanotide given as repeated subcutaneous injections.
The current study is designed to validate our hypothesis that increases in blood pressure and gastrointestinal events seen with intranasally administered bremelanotide were primarily related to high intranasal absorption in a subset of patients. The results from this study in the male demographic we are targeting for commercialization, combined with results from our study reported last August, are intended to further address concerns raised by the Food and Drug Administration,” said Trevor Hallam, Ph.D., Executive Vice President of Research and Development of Palatin.