Sep 11 2012
Palatin Technologies, Inc. (NYSE MKT: PTN) today announced that the last patient has completed treatment in its Phase 2B clinical trial evaluating the efficacy and safety of bremelanotide for treatment of female sexual dysfunction (FSD). Database lock is expected by the end of September and top-line trial results are expected in the first-half of next quarter.
"We are pleased to reach this important milestone of completing the patient treatment part of this comprehensive trial and look forward to compiling and analyzing the data," stated Carl Spana, Ph.D., President and CEO of Palatin. "Bremelanotide is the only on-demand treatment for FSD in clinical trials in the United States, and has the potential to transform the treatment of patients with FSD."
Approximately 400 premenopausal women, diagnosed with female sexual arousal disorder, hypoactive sexual desire disorder or both, were enrolled in the study. Patients were treated for 16 weeks and were randomized to one of four double-blind treatment groups and received placebo or bremelanotide doses of 0.75, 1.25, or 1.75 milligrams.
The trial is a multi-centered, placebo-controlled, randomized, parallel-group trial designed to measure the safety and efficacy of subcutaneous (SC) bremelanotide doses intended for on-demand use in premenopausal females with FSD. The pharmacokinetics of SC bremelanotide will also be assessed during this trial.
The objectives of the Phase 2B trial are to demonstrate and identify safe and effective SC doses of bremelanotide and to define endpoint measurements to support transition to Phase 3 studies. Depending on the results of this trial, Phase 3 studies are anticipated to start in the second-half of calendar year 2013.
SOURCE Palatin Technologies, Inc.
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