Also below is the JAMA abstract for those who are interested.

Study: Johnson & Johnson’s Topamax may help reduce alcohol dependency
by Alison Fischer
Study results demonstrated that more heavy drinkers who received Johnson & Johnson’s Topamax (topiramate) quit drinking by the end of the trial, compared with those who received placebo, according to findings published in the current issue of JAMA.

The company-sponsored, 14-week study enrolled 371 men and women who were heavy drinkers. About half the participants received placebo, and half Johnson & Johnson’s drug. The findings showed that 27 of 183 patients taking Topamax stopped drinking by the end of the trial, compared with 6 of 188 patients given placebo. The data also demonstrated that Topamax was more effective at reducing the percentage of heavy-drinking days, compared with placebo.

The drugmaker indicated that it does not plan to conduct further testing or seek FDA approval for Topamax as a treatment for alcohol dependency. Nonetheless, in an editorial accompanying the study, Mark Willenbring, a director at the National Institute on Alcohol Abuse and Alcoholism, stated that “we now have very high-quality evidence that shows efficacy. The medical world doesn’t wait for the indication.”

However, Sidney Wolfe, director of the Health Research Group at Public Citizen, raised concerns that a press kit about the study from the University of Virginia promoted use of Johnson & Johnson’s drug as a treatment for alcoholism. Wolfe asked the US regulatory agency to stop an “illegal and dangerous promotional campaign” linked to the study, adding that “it is not the research or the publication of the study that is illegal but the promotional material that goes beyond the research to solicit new sales for the drug.”

A spokesperson for Johnson & Johnson commented that company “does not support any reference to off-label use of our products. We only promote the use of Topamax for the approved indications of migraine prevention and epilepsy.”

JAMA Abstract
Context: Hypothetically, topiramate can improve drinking outcomes among alcohol-dependent individuals by reducing alcohol’s reinforcing effects through facilitation of -aminobutyric acid function and inhibition of glutaminergic pathways in the corticomesolimbic system.

Objective: To determine if topiramate is a safe and efficacious treatment for alcohol dependence.

Design, Setting, and Participants: Double-blind, randomized, placebo-controlled, 14-week trial of 371 men and women aged 18 to 65 years diagnosed with alcohol dependence, conducted between January 27, 2004, and August 4, 2006, at 17 US sites.

Interventions: Up to 300 mg/d of topiramate (n = 183) or placebo (n = 188), along with a weekly compliance enhancement intervention.

Main Outcome Measures: Primary efficacy variable was self-reported percentage of heavy drinking days. Secondary outcomes included other self-reported drinking measures (percentage of days abstinent and drinks per drinking day) along with the laboratory measure of alcohol consumption (plasma -glutamyltransferase).

Results: Treating all dropouts as relapse to baseline, topiramate was more efficacious than placebo at reducing the percentage of heavy drinking days from baseline to week 14 (mean difference, 8.44%; 95% confidence interval, 3.07%-13.80%; P = .002).

Prespecified mixed-model analysis also showed that topiramate compared with placebo decreased the percentage of heavy drinking days (mean difference, 16.19%; 95% confidence interval, 10.79%-21.60%; P < .001) and all other drinking outcomes (P < .001 for all comparisons).

Adverse events that were more common with topiramate vs placebo, respectively, included paresthesia (50.8% vs 10.6%), taste perversion (23.0% vs 4.8%), anorexia (19.7% vs 6.9%), and difficulty with concentration (14.8% vs 3.2%).

Conclusion: Topiramate is a promising treatment for alcohol dependence.