Cocaine treatment gives investors a high

Nostrils were wide open on Wall Street today to take in the results of a study for vigabatrin, an experimental med that is being tested to fight cocaine addiction. Shares in Catalyst Pharmaceuticals rose more than 11 percent following publicity about a Phase II study showing the drug worked in a meaningful number of patients, who were prison parolees.
The results indicated a statistically significantly greater number of patients given vigabatrin were able to abstain from cocaine during the last three weeks of the dosing period, compared to those receiving placebo. The primary outcome measure of the trial was negative urine tests for cocaine for the last three weeks of the nine-week trial, and a total of 18 patients, or 42 percent of the 103 who were enrolled, fulfilled the criteria. Of these, 14, or 28 percent, were treated with vigabatrin versus four, or 7.6 percent, who were treated with placebo.
“Typically, in anti-addiction trials of this size the difference between drug and placebo groups is expected to be approximately 30 percent, a level that may not necessarily translate into clinical meaningfulness subsequently,” writes Elemer Piros, a biotech analyst at Rodman & Renshaw, in an investor note. “The study demonstrated a high level of statistical significance, regardless of whether the statistical analysis of the primary endpoint included covariates (number of years of cocaine use and average amount of cocaine use at baseline) or not.”
The drug, by the way, works by indirectly lowering the level of dopamine in the brain, which causes the high associated with drug abuse. Catalyst says it expects initial top-line results of the Phase II clinical trials to be available during the summer of 2008, and also plans to have the full data set presented at scientific meetings next year. Meanwhile, Phase II trials for methamphetamine addiction are supposed to begin next year.
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