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Catalyst Pharmaceutical Partners, Inc. Begins Enrollment for U.S. Phase II Clinical Trial of CPP-109 in Patients with Methamphetamine Addiction
Date:6/30/2008

U.S. Phase II trial with CPP-109, this time as a potential treatment for methamphetamine addiction. As with cocaine, we believe that CPP-109 may offer the potential to provide patients suffering from methamphetamine addiction, as well as the physicians and clinicians that treat them, with a safe and effective pharmacotherapy option."

The Phase II trial is designed as a randomized, double-blind, placebo-controlled, intent-to-treat, multicenter trial to evaluate the safety and efficacy of CPP-109 as a treatment for methamphetamine addiction. The trial is expected to enroll 180 methamphetamine addicted patients at 15 leading addiction treatment clinical centers in the United States. Patients will be treated for a period of 12 weeks, with an additional 12 weeks of follow-up. The primary endpoint of the study is to demonstrate that a larger proportion of CPP-109-treated subjects than placebo-treated subjects will be methamphetamine-free during their last two weeks of treatment (Weeks 11 and 12). Additionally, Catalyst will be measuring several secondary endpoints based on reduction in craving and of methamphetamine use.

"Vigabatrin has previously shown the potential to be a non-addictive drug treatment for cocaine and methamphetamine addiction in two pilot studies and one Phase II double-blind trial conducted in Mexico. We are excited to now be able to seek to determine the therapeutic benefit of our product in methamphetamine addicted patients enrolled in a larger, well-designed, placebo-controlled trial conducted under our sponsorship," said Douglas Winship, Vice President of Regulatory Operations for Catalyst. "There are currently no adjunctive drug products approved for the treatment of this population. As a result, drug therapies are desperately needed which can improve abstinence achievement rates of behavioral therapy currently obtained by addiction treatment specialists, and reduce recidivism."

About Methamphetamine Addiction

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SOURCE Catalyst Pharmaceutical Partners, Inc.
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