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news.Catalyst Pharmaceutical has announced top line results for phase II clinical trial for CPP-109. The data from the trial showed that a significantly larger proportion of CPP-109 treated subjects were cocaine free during the last two weeks of the treatment period (weeks 11 and 12), as compared to the placebo treated subjects.
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Catalyst intends to investigate the reasons for the disparity between the trial results and previously published clinical and non-clinical results evaluating vigabatrin as a treatment for cocaine addiction. Complete analyses of the clinical trial data are underway.
Patrick J. McEnany, Chairman, President and CEO of Catalyst, 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. We also expect to have the results of our methamphetamine proof-of-concept study during the third quarter, which will provide us with data that we can use to assess the next steps in our strategy, he added.