Catalyst Pharmaceutical Partners, NIDA to jointly conduct Phase II(b) trial of CPP-109 for cocaine addiction

Apr 15 2010

Catalyst Pharmaceutical Partners, Inc. (NasdaqCM: CPRX) announced today that it has signed a definitive Clinical Trial Agreement (CTA) with the National Institute on Drug Abuse (NIDA) to jointly conduct a U.S. 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 Program, will provide substantial resources for the estimated $10 million trial cost. Catalyst will contribute approximately $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 enroll 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 enrollment of patients this summer and expect to have top-line results in the fourth quarter of next year."

"Currently, there are no 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 FDA."