CORAL GABLES, Fla., Sept. 24, 2012 (GLOBE NEWSWIRE) -- Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX) announced today that researchers at Mount Sinai School of Medicine in New York have commenced a safety and tolerability trial of vigabatrin in young adults with treatment refractory Tourette's Disorder (TD) to evaluate whether CPP-109 (vigabatrin) can potentially reduce the severity of debilitating tics. The researchers hope that the results from their study of CPP-109 will provide initial evidence of efficacy to support the conduct of a larger clinical trial and FDA approval of CPP-109 for the treatment of refractory Tourette's Disorder.
This study will be conducted by a team of researchers led by Barbara J. Coffey, M.D., M.S., Director, Tics and Tourette's Clinical and Research Program and Professor, Department of Psychiatry at Mount Sinai School of Medicine. In this open label trial, subjects will receive CPP-109 for eight weeks. The aims of this study are to: 1) explore proof-of-concept that CPP-109 will reduce severity of tics, and 2) obtain systematic data regarding dosing, safety and tolerability of CPP-109 in adults with treatment refractory TD. Recruitment is targeted to be completed in 12 months. The study is being conducted at Mount Sinai School of Medicine's Behavioral Science Unit. Catalyst is providing CPP-109 study medication and financial support to facilitate the study.
"A substantial minority of patients with Tourette's Disorder continue to experience debilitating and functionally impairing tics throughout their lives," said Barbara Coffey, M.D., M.S., the principal investigator for the trial. "New, more tolerable and efficacious medications are urgently needed for these patients to improve their quality of life. Investigation of new agents with a mechanism of action that may target specific brain functions in TD is truly innovative.""Tourette's Disorder, as with many psychiatric disorders, is thought to involve dysregulation of dopamine transmission as a significant component," said Jonathan Brodie, M.D., Ph.D., Professor of Psychiatry, NYU School of Medicine and a co-inventor on the patent application for the use of GABA-aminotransferase inhibitors to treat Tourette's Disorder. "I believe that treatment with such inhibitors may provide a useful alternative for patients whose tics are refractory to current treatment."