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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

CORAL GABLES, Fla., Sept. 30 /PRNewswire-FirstCall/ -- Catalyst Pharmaceutical Partners, Inc. (Nasdaq: CPRX) today announced that the Company will continue to develop CPP-109 (Catalyst's version of vigabatrin) for the treatment of cocaine and methamphetamine addiction. The Company's decision was made after, and based upon, an in-depth review of the results obtained from its 186-patient Phase II clinical trial evaluating the use of CPP-109 for the treatment of cocaine addiction (CPP-01004) and the top-line results obtained from its 57-patient proof-of-concept study evaluating the use of CPP-109 for the treatment of methamphetamine addiction (CPP-02001). Catalyst's decision to continue the development of the drug for both indications was supported by a panel of experts who recently met and agreed with the Company's conclusion that there was sufficient evidence of safety and efficacy to justify further development of CPP-109, based upon these trial data and previously published studies of vigabatrin to treat addiction.

Cocaine Trial Results

After post-hoc analyses of vigabatrin levels in urine samples collected during the study, Catalyst concluded that less than 40% of the trial subjects were medication compliant. As a result, the study was inadequately powered to test the protocol-specified efficacy hypotheses. On the basis of a comprehensive review of all study data, however, it was concluded that: (i) CPP-109 was safe and well tolerated; and (ii) while there were no statistically significant differences between active and placebo groups for the protocol-specified primary and secondary efficacy endpoints, there were positive and consistent data trends observed in favor of CPP-109 across measures of cocaine abstinence, reduction in use, and reduction in use days.

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SOURCE Catalyst Pharmaceutical Partners
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