Palatin Technologies completes first cohort dosing in bremelanotide trial for sexual dysfunction

Feb 10 2010

Palatin Technologies, Inc. (NYSE Amex: PTN) 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.

Palatin anticipates completing the study in the current calendar quarter, with data analysis completed in the next calendar quarter.

"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.

Data from this study will be submitted to the Food and Drug Administration.  Palatin intends to initiate a Phase 2, at-home, study of subcutaneous bremelanotide in men with erectile dysfunction who are not responsive to therapies with drugs such as Viagra®, a brand of sildenafil citrate, in the second half of this calendar year.  The Phase 2 bremelanotide erectile dysfunction program is designed to provide the data required to initiate Phase 3 registration trials.

"The commercial opportunity for bremelanotide is significant with an estimated market of $500 million to $600 million per year.  About 35% of patients with erectile dysfunction 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.