Patrick J. McEnany, Chief Executive Officer of Catalyst, commented: "We are very pleased to announce the start of active enrollment in our study of CPP-109 as a potential treatment for cocaine addiction. We expect to add more clinical trial sites to the 10 previously disclosed in order to complete the trial as soon as possible. We anticipate initial top-line results from this trial to be available by year-end."
Douglas Winship, Catalyst's Vice President of Regulatory Operations, stated: "Vigabatrin has previously shown the potential to be a safe and effective non-addictive drug treatment for cocaine and methamphetamine addiction in a Phase II double-blind, placebo-controlled trial and two pilot studies conducted in Mexico. We are excited to now evaluate the therapeutic benefit of CPP-109 in cocaine-addicted patients enrolled in a large, double- blind, placebo-controlled trial conducted in the U.S. under our sponsorship. There are currently no prescription drugs approved for the treatment of this population. As a result, drug therapies are desperately needed which can improve abstinence achievement rates of behavioral therapy administered by addiction treatment specialists, and reduce recidivism. We have worked diligently with regulatory authorities and the independent institutional review boards at each of the clinical sites where our trial will be conducted to be able to finalize and implement our protocol for this trial."
On December 7, 2007, Catalyst announced positive initial top-line results from a 103-patient, investigator-initiated Phase II double-blind, placebo- controlled trial, in which vigabatrin met its primary efficacy endpoint of abstinence during the last weeks of treatment for cocaine addiction. Additional results of this study will be reported when they become available.
CPP-109 works by inhibiting an enzyme that normally breaks down gamma
|SOURCE Catalyst Pharmaceutical Partners, Inc.|
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