The primary endpoint in the double-blind safety study is evaluation of blood pressure effects of subcutaneous Bremelanotide in men between 45 and 65 years old. The study is also expected to evaluate consistency of plasma exposure of Bremelanotide given as repeated subcutaneous injections.
The company said that the data from this study will be submitted to the FDA. 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 year. The Phase 2 Bremelanotide erectile dysfunction program is designed to provide the data required to initiate Phase 3 registration trials.
Trevor Hallam, executive vice president of research and development at Palatin, said: “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 commercialisation, combined with results from our study reported last August, are intended to further address concerns raised by the FDA.”