Catalyst Pharmaceutical Partners has signed a clinical trial agreement (CTA) with the US National Institute on Drug Abuse (NIDA) to jointly conduct test trials for a new drug to treat cocaine addiction.
The phase II(b) clinical trial will evaluate CPP-109, a GABA aminotransferase inhibitor, Catalyst's formulation of vigabatrin.
As part of the CTA, NIDA, under their agreement with Veterans Administration Cooperative Studies Program will fund the trial estimated to cost US$10m. Catalyst will contribute approximately $2.8m in resources.
The double-blind, placebo-controlled trial will enroll approximately 200 patients and will be conducted at eight leading addiction facilities across the US.
The clinical trial is designed to confirm the safety and efficacy of CPP-109 for the treatment of cocaine addiction.
NIDA's division of pharmacotherapies and medical consequences of drug abuse associate director David McCann said that currently, there are no FDA-approved medications to battle cocaine addiction.
"We are encouraged by findings from prior animal and human studies that suggest this medication as a treatment for the nation's estimated 2.1 million cocaine abusers," McCann said.
The company expects to commence the enrollment of patients with results expected in the fourth quarter of next year.