Coral Gables, Fla. — Catalyst Pharmaceutical Partners, Inc, a development-stage biopharmaceutical company focused on prescription drugs targeting addiction and diseases of the central nervous system, has announced that researchers at the University of Pennsylvania have commenced a 60-subject, double-blind, placebo-controlled, investigator-sponsored study to evaluate the use of CPP-109 (vigabatrin) for the treatment of patients addicted to both cocaine and alcohol.
The researchers hope that the results from their study of CPP-109 will support the conduct of a larger clinical trial that could support FDA approval of CPP-109 as a treatment for cocaine and alcohol co-dependency. Such results, if successful, would also expand upon the initial promising results reported by Brodie, et al. in November 2009 in the American Journal of Psychiatry, in which significantly increased abstinence from alcohol use in subjects taking vigabatrin was also reported.
This study will be conducted by a team of researchers led by Kyle M. Kampman, MD, Associate Professor of Psychiatry through his affiliation with the University of Pennsylvania School of Medicine's Treatment Research Center. In this trial, 60 subjects will receive either CPP-109 or matching placebo, in addition to weekly counseling for eight weeks. The primary outcome measures are cocaine abstinence confirmed by twice weekly urine drug screens and alcohol abstinence measured by self-report. Recruitment is targeted to be completed in 12 months. The study is being conducted at the University of Pennsylvania Treatment Research Center.
Catalyst will provide CPP-109 and matching placebo, and financial support to conduct eye-safety examinations to facilitate the study. The National Institute on Drug Abuse (NIDA) is providing the majority of funding for the study as a part of the pilot study program included in a P50 center grant headed by Helen Pettinati, Ph.D., Research Professor of Psychiatry.
This study is part of pilot project program being conducted at the University of Pennsylvania, the goal of which is to rapidly screen medications for the treatment of comorbid cocaine and alcohol dependence in small clinical trials. The pilot project program seeks to utilize state of the art techniques to ensure excellent medication adherence and treatment retention so that reliable results can be obtained rapidly to inform future larger trials.
Patrick J. McEnany, Catalyst's CEO, commented, "We are very pleased to collaborate with the University of Pennsylvania on this important study in addition to our on-going NIDA collaboration for our Phase II(b) cocaine dependence trial. NIDA's commitment to these trials continues to support the potential of CPP-109 for treating substance addiction."
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