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Catalyst Pharmaceutical Partners Continues Clinical Development of CPP-109 For The Treatment of Cocaine and Methamphetamine Addiction
Date:9/30/2009

sychiatry).

Douglas Winship, Catalyst's Vice President of Regulatory Operations, commented, "The CPP-01004 clinical trial was a landmark first-in-class U.S. study and to our knowledge, the first large trial conducted in cocaine-dependent subjects of an orally administered medication in which extensive post-hoc objective measurements of medication levels in subjects to verify compliance were performed. Addicted subjects are an extremely difficult and unreliable population in which to conduct clinical trials. In addition, there are no established FDA guidelines for addiction trials. Based on numerous publications of data from previous addiction trials in which historical compliance rates of greater than 85% as measured by pill count and self-report were reported, we believed that our trial was sufficiently powered with 180 subjects. Unfortunately, due to the significantly lower verified actual compliance we found in our trial, there was insufficient power to detect a statistically significant difference between CPP-109 and placebo on the primary or secondary efficacy outcomes. We will continue to complete additional analysis as part of our goal to present our results at appropriate medical conferences in the coming months."

Methamphetamine Study Results

The methamphetamine proof-of concept study enrolled 57 subjects (29 on vigabatrin and 28 on placebo) and there was a 2.5 times higher rate of abstinence in the last two weeks (11 and 12) of the study in the vigabatrin group versus placebo. While this is an encouraging trend, it was not statistically significant due to the small number of subjects in the study. Catalyst further believes that medication compliance may have been below expectations for this study as well.

CPP-109 (Vigabatrin) Safety Results

Regarding the safety of CPP-109, no clinically significant abnormalities in visual fields and visual acuity were found in any subject in
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SOURCE Catalyst Pharmaceutical Partners
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