Catalyst Pharmaceutical has signed an agreement with the National Institute on Drug Abuse (NIDA) to jointly conduct a US Phase II (b) trial for vigabatrin to treat cocaine addiction.
Catalyst plans to conduct the double-blind, placebo-controlled trial at eight addiction facilities across the US, enrolling 200 patients.
The trial is designed to evaluate the safety and efficacy of CPP-109, Catalyst’s formulation of vigabatrin, as a treatment for this addiction, for which there are currently no FDA-approved medications.
Catalyst is expecting the key trial data in the fourth quarter of 2011.
Under the agreement, NIDA will provide the majority of resources for the estimated $10m trial cost, while Catalyst will contribute $2.8m in resources.
There are an estimated 2.1 million cocaine abusers in the US.