CRANBURY, N.J., May 14, 2013 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE MKT: PTN), a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, today announced financial results for the third quarter ended March 31, 2013. The Company also summarized end-of-Phase 2 discussions with the U.S. Food and Drug Administration (FDA) and next steps for its Phase 3 pivotal registration program for bremelanotide, its product in development as a novel treatment for female sexual dysfunction (FSD). Palatin will hold a conference call and live audio webcast later today.
End-of-Phase 2 Meeting with FDA on Bremelanotide for FSD
In the end-of-Phase 2 meeting with FDA, Palatin reached preliminary agreement on key aspects of the Phase 3 pivotal registration studies, including:
In addition, the FDA agreed with Palatin's position that the blood pressure and heart rate signals of bremelanotide had been adequately characterized during the Phase 2 program. The FDA also agreed with the proposed Phase 3 blood pressure monitoring program, which will consist of standardized methods for in-clinic assessment of blood pressure.
"We view our positive meeting with the FDA as a major milestone in the development of bremelanotide for FSD. We are pleased to have concurrence from the FDA on the design and selection of efficacy endpoints of our Phase 3 clinical studies," stated Carl Spana, Ph.D., President and CEO of Palatin. "We are also pleased with the FDA's concurrence that the blood pressure monitoring program for our Phase 3 clinical studies only includes standardized methods for in-clinic assessment of blood pressure. We look forward to advancing bremelanotide for FSD towards a suc
|SOURCE Palatin Technologies, Inc.|
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