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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

ation compliance by subjects, consistent trends in favor of CPP-109 over placebo were observed after the post-hoc analyses with respect to both primary and secondary efficacy endpoints. When corrected for poor medication compliance, the following favorable outcome trends were observed: (i) the log10 benzoylecgonine (the major metabolite of cocaine) levels measured in urine collected from subjects were consistently lower in the CPP-109 treatment group during the 12 week treatment period, generally indicating a reduction of cocaine use; and (ii) in those subjects who were compliant with study medication, the differences between CPP-109 and placebo were amplified, which suggest that CPP-109 may facilitate abstinence, reduce overall cocaine use as measured by urine benzoylecgonine levels (an objective measure of daily cocaine usage), and reduce cocaine usage days (an objective measure of dependence severity).

Consistent with previous published addiction trials, the protocol in the Company's cocaine trial assessed subjects' medication compliance based on self reporting and on counting the unused medication returned by subjects. Based on that methodology, the Company had an 85% compliance level. However, after post-hoc testing of urine samples from many of the trial's subjects, the Company has concluded that less than 40% of the trial subjects were compliant taking their medication. As a practical matter, the low medication compliance effectively reduced the power of the study because not all subjects in the treatment group were actually treated. However, analyses of subject responses, corrected for poor compliance, makes the response ratios observed in the Company's trial more consistent with the results reported by Dr. Jonathan Brodie et al. in a double-blind, placebo-controlled, 103-patient Phase II trial evaluating vigabatrin for the treatment of cocaine addiction (the results of which were recently published on-line in The American Journal of P
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