Catalyst Pharmaceutical Partners, Inc has signed a definitive Clinical Trial Agreement (CTA) with the National Institute on Drug Abuse (NIDA) to jointly conduct a US phase-II(b) clinical trial evaluating CPP-109, Catalyst's formulation of vigabatrin, for the treatment of cocaine addiction. As part of the CTA, NIDA, under their agreement with Veteran's Administration Cooperative Studies Programme, will provide substantial resources for the estimated US$ 10 million trial cost. Catalyst will contribute approximately US$ 2.8 million in resources.

"We are delighted to be partnered with NIDA to conduct this new trial," said Patrick J McEnany, chief executive officer of Catalyst. "NIDA's commitment to this trial further validates our decision to continue developing CPP-109 for cocaine addiction. We anticipate that this double-blind, placebo-controlled trial will enrol approximately 200 patients and will be conducted at eight leading addiction facilities across the United States. The clinical trial is designed to confirm the safety and efficacy of CPP-109 for the treatment of cocaine addiction. We are finalizing the details of the trial, and expect to commence enrolment of patients this summer and expect to have top-line results in the fourth quarter of next year."

"Currently, there are no US FDA-approved medications to battle cocaine addiction," said Dr David McCann, associate director, Division of Pharmacotherapies and Medical Consequences of Drug Abuse, NIDA. "We are involved because we are encouraged by findings from prior animal and human studies that suggest promise for this medication as a treatment for the nation's estimated 2.1 million cocaine abusers."

"We will build on the knowledge and experience gained from the five previous human trials that have been conducted with vigabatrin to treat cocaine and methamphetamine addiction, in particular with respect to assuring medication compliance," said Douglas Winship, Catalyst's vice president of Regulatory Operations. "This partnership will enable us to conduct a phase-II(b) registration-directed trial of CPP-109 as required by the US FDA."

Catalyst Pharmaceutical Partners is a development-stage biopharmaceutical company focused on the development and commercialization of prescription drugs targeting diseases of the central nervous system with a focus on the treatment of drug addiction and epilepsy.