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Catalyst Pharmaceutical Partners Announces Positive Phase II Trial Results for Vigabatrin in the Treatment of Cocaine Addiction
Date:12/7/2007

ruggling with cocaine addiction will be treated in the future. We believe that the success of the trial provides scientific proof of concept. We are highly encouraged by the top-line results and look forward to publication of the results in a peer-reviewed journal. Catalyst will also evaluate the methodology and results for their potential applicability to our ongoing U.S. Phase II trial evaluating CPP-109 for the treatment of cocaine addiction and to our planned U.S. Phase II trial evaluating CPP-109 for the treatment of methamphetamine addiction."

About The Trial

This trial is the third in a series of human trials conducted in Mexico, which successfully tested the safety and efficacy of vigabatrin to treat cocaine and/or methamphetamine addiction. These trials followed more than 15 years of animal studies conducted by Dr. Stephen Dewey at Brookhaven National Laboratory. All three human trials were conducted under the direction of Dr. Jonathan Brodie, the Marvin Stern Professor of Psychiatry at the New York University (NYU) School of Medicine and Dr. Emilia Figueroa, Director of the Clinica Integral de Tratamiento Contra las Adicciones, S.A. de C.V. The first two trials were small open-label studies. The trial's protocol was approved by NYU's Institutional Review Board in May 2006 and the Federal Commission for Sanitary Risks Protection (Mexico) in September 2006 and is registered at http://www.clinicaltrials.gov with the identifier NCT00527683. Catalyst provided financial support through an unrestricted gift to NYU.

One hundred and three community-based, non-hospitalized cocaine addicted individuals participated in this investigator-initiated, randomized, double- blind, placebo-controlled trial conducted at a single site in Mexico City. All subjects had ready access to cocaine and were self-motivated to stop their use. The trial was designed to show whether vigabatrin treatment could si
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SOURCE Catalyst Pharmaceutical Partners, Inc.
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