Developing a Drug to Fight Drug Addiction

Catalyst is a specialty pharmaceutical company of Coral Gables, Florida, that acquires or in-licenses, develops and commercializes prescription drugs for the treatment of drug addiction. Catalyst is developing vigabatrin (designated CPP-109 by Catalyst) for the treatment of addiction to cocaine, methamphetamine and other addictive substances.

The National Institute on Drug Abuse has stated that finding a pharmacological treatment for cocaine addiction is their number one research priority.

The U.S. Food and Drug Administration has recognized that cocaine addiction is a "serious, life-threatening condition for which there is no current drug treatment," and the National Institute on Drug Abuse (NIDA) has stated that finding a pharmacological treatment for cocaine addiction is their number one research priority. Because of the high social and financial cost of addiction, Catalyst's mission to develop a treatment for drug addiction could prove beneficial not only to addicts, but to investors and to society at large.

Previous studies in established animal models of addiction, involving both rats and primates, have shown that vigabatrin interrupts the neural mechanisms essential for addiction. In preclinical studies, vigabatrin prevented the characteristic drug-seeking behavior of addicted animals.

Three human trials of vigabatrin have been completed in Mexico with patients addicted to cocaine or methamphetamine, including a U.S. Phase II 103-patient, double-blind, placebo-controlled trial completed in 2007. Data from these three trials provide clinical evidence of vigabatrin's potential as a safe and effective treatment for patients with these addictions.

In January 2008, Catalyst initiated enrollment of patients for a U.S. Phase II 180-patient, multi-center, double-blind, placebo-controlled clinical trial evaluating the use of CPP-109 in treating patients with cocaine addiction (details here).

Stephen Dewey, PhD
Stephen L. Dewey, PhD, researcher on vigabatrin
courtesy Brookhaven National Laboratory

Most of the research on vigabatrin to treat addiction has emerged from work performed over the last 12 years at the Brookhaven National Laboratory (Brookhaven). Brookhaven holds various patents relating to its research findings.

Catalyst has obtained from Brookhaven an exclusive worldwide license for nine patents and seven patents pending in the United States for all rights to use or sell vigabatrin for the treatment of addiction to cocaine, methamphetamine, prescription pain medications, heroin, nicotine and other addictive drugs. In addition, Catalyst's license includes rights to Brookhaven's foreign patents or patents pending in more than 30 countries.