Catalyst drug found effective against cocaine addiction

This 103 subject trial is the first randomized, double-blind, placebo- controlled clinical trial studying vigabatrin’s effectiveness in treating cocaine addiction. These data show that a statistically significantly greater number of subjects treated with vigabatrin were able to abstain from cocaine usage during the last three weeks of the dosing period compared to those receiving placebo. The data confirm the positive results seen in two previous open-label trials conducted in 2003 and 2004 by the same investigators.

This trial is the third in a series of human trials conducted in Mexico, which successfully tested the safety and efficacy of vigabatrin to treat cocaine and/or methamphetamine addiction. One hundred and three community-based, non-hospitalized cocaine addicted individuals participated in this investigator-initiated, randomized, double- blind, placebo-controlled trial conducted at a single site in Mexico City. All subjects had ready access to cocaine and were self-motivated to stop their use. The trial was designed to show whether vigabatrin treatment could significantly increase abstinence compared to placebo. Subjects were randomly assigned to either a placebo or vigabatrin and were treated for a period of nine weeks. Of the 103 participants in the trial, 50 were treated with vigabatrin and 53 received placebo. Twice-weekly urine screening tests were obtained from each subject in order to objectively evaluate each subjects’s cocaine use. The primary outcome measure of the trial was negative urine tests for cocaine for the last three weeks of the nine-week trial.

A total of 18 subjects fulfilled the criteria for the primary outcome measure. Of these, 14 (28%) were treated with vigabatrin versus four (7.6%) who were treated with placebo. A logistic regression utilizing years of cocaine use and average amount per day at baseline yielded statistically significant treatment differences. The p-value was 0.009. There were no serious adverse events reported in this trial.

Patrick McEnany, chairman and CEO, Catalyst Pharmaceuticals said: “Catalyst will evaluate the methodology and results for their potential applicability to our ongoing US Phase II trial evaluating CPP-109 for the treatment of cocaine addiction and to our planned US Phase II trial evaluating CPP-109 for the treatment of methamphetamine addiction.”