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The data from the trial showed that CPP-109 did not demonstrate statistical significance in the primary endpoint - that a significantly larger proportion of CPP-109-treated subjects than placebo-treated subjects were cocaine-free during the last two weeks of the treatment period (weeks 11 and 12). The clinical trial did not reveal any unexpected 'serious' adverse events.
Complete analyses of the clinical trial data are ongoing. Based on the results of these analyses, Catalyst will evaluate what measures, if any, could be applied to improve the outcome of future studies and will also determine next steps to be taken regarding the development of CPP-109 for the treatment of cocaine addiction.
In addition, Catalyst intends to investigate the reasons for the disparity between these trial results and previously published clinical and non-clinical results evaluating vigabatrin as a treatment for cocaine addiction. Catalyst expects to complete the analyses during the third quarter after fully unblinding the trial data and will then formulate future development plans.
Patrick McEnany, chairman, president and CEO, said: "We are obviously disappointed in the cocaine trial results, given the positive results of three prior human trials and numerous animal studies; however, we are not ready to abandon our view that CPP-109 has the potential for use in treating cocaine addiction, which still represents a significant unmet medical need.
"We will carefully study the results of our trial and assess the appropriate path for conducting future clinical trials evaluating CPP-109 for the treatment of cocaine addiction."
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