Palatin Technologies, Inc. (NYSE Amex: PTN) announced today that enrollment of patients has commenced in Palatin's Phase 2b clinical trial evaluating the efficacy and safety of bremelanotide (previously called PT-141), an on-demand, first-in-class melanocortin agonist being developed for the treatment of female sexual dysfunction (FSD).
The multicenter study is a placebo-controlled, randomized, parallel group, dose-finding trial that will test three dose levels of subcutaneously administered bremelanotide in premenopausal women diagnosed with female sexual arousal disorder (FSAD) and/or hypoactive sexual desire disorder (HSDD).
The study is expected to enroll 400 premenopausal women across 40 sites within the U.S. and Canada, with a target of randomizing 100 patients to each of three treatment arms and a placebo arm. Patients will undergo 16 weeks of treatment.
The objective of the Phase 2b trial is to measure safety and efficacy of subcutaneous doses intended for on-demand, home use. The primary efficacy endpoint is change from baseline to end of study in the number of satisfying sexual events (SSE).
"We are very excited to have begun patient enrollment for the Phase 2b study of bremelanotide, the most advanced on-demand investigational treatment for FSD. Pending successful completion of the trial, the data will be used to support discussions with the FDA prior to initiation of Phase 3 studies," stated Carl Spana, Ph.D., President & CEO of Palatin. "We believe bremelanotide has the potential to transform the treatment of patients with FSD, an area of significant unmet need."
Results from this study are anticipated in the second half of calendar year 2012 and will guide the final design of anticipated Phase 3 studies.
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