Palatin Technologies, Inc. (NYSE Amex: PTN) today announced the completion of patient dosing and database lock in a double-blind, placebo-controlled, multiple dose, crossover study of bremelanotide, its subcutaneously administered melanocortin agonist for treatment of erectile dysfunction (ED). Palatin expects to report top-line data in the next calendar quarter.
The endpoints in the study are evaluation of plasma exposure and blood pressure, at rest and under exercise stress, in men between 45 and 65 years old, the target demographic. A total of 49 subjects were dosed in the study.
"The current study was designed to provide sufficient confidence in the new route of administration to support further development. We are excited to have completed this safety study and look forward to evaluating this opportunity to bring benefit to patients with erectile dysfunction who do not respond to approved oral therapies," stated Trevor Hallam, Ph.D., Executive Vice President of Research and Development of Palatin.
Based on Palatin's internal review of the data and guidance from an external cardiovascular clinical advisory panel, Palatin intends to submit protocol proposals to Food and Drug Administration for Phase 2, at-home studies of subcutaneous bremelanotide in men with erectile dysfunction who are not responsive to phosphodiesterase-5 inhibitors such as Viagra®, a brand of sildenafil citrate. Phase 2 bremelanotide studies, designed to provide the data required to initiate Phase 3 registration studies, are planned to start as early as the 4th quarter of this calendar year.
"We are excited by the significant commercial opportunity for bremelanotide. 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 represents a large market opportunity with no FDA approved drugs."
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