Oct. 9 (Bloomberg) -- Johnson & Johnson's seizure medicine Topamax helped alcoholics cut their drinking, according to research that may lead to a new approach to fighting the addiction.

The study, appearing in tomorrow's Journal of the American Medical Association, found that Topamax, also approved in the U.S. for the treatment of migraines, helped alcoholics reduce the number of days they spent drinking heavily.

Topamax isn't approved for use in alcoholics and Johnson & Johnson said today it won't conduct further trials or seek U.S. approval for the medicine for alcohol dependency. Still, Mark Willenbring, a director at the National Institute on Alcohol Abuse and Alcoholism in Bethesda, Maryland, said that won't stop doctors from using the drug anyway, called ``off label'' prescribing.

``We now have very high-quality evidence that shows efficacy. The medical world doesn't wait for the indication,'' said Willenbring, who wrote an editorial that accompanies the study, in a telephone interview today. ``Topamax is a drug that many physicians have used and many patients have had an experience with because of its use in migraines.''

About 18 million people in the U.S. have drinking problems. Alcohol contributes to 100,000 deaths each year, making it the third-leading cause of preventable death in the U.S. behind smoking and obesity, according to the National Council on Alcoholism and Drug Dependence.

Brain Chemicals

Topamax is thought to restore balance in the levels of chemicals released in the brain that are affected by alcoholism, said Bankole Johnson, a professor at the University of Virginia in Charlottesville and the study's lead author, in an interview.

``First, it reduces your craving for alcohol; second, it reduces the amount of withdrawal symptoms you get when you start reducing alcohol; and third, it reduces the potential for you to relapse after you go down to a low level of drinking or zero drinking,'' Johnson said. ``I wouldn't say it's a cure; I would say it's a very big improvement over what we've had before. We will continue working toward a cure.''

The company-sponsored study followed 371 men and women who were heavy drinkers for 14 weeks. About half were given a placebo. Results showed that 27 of 183 patients, or 15 percent, taking Topamax quit drinking by the end of the study. That compares with 6 participants, or 3.2 percent, of 188 given a placebo.

Less Heavy Drinking

The study also found that those taking Topamax had an average 8.4 percent fewer heavy drinking days than those given a placebo. One drink is considered a 10-ounce beer (283.5 grams), four ounces of wine or 1 ounce of 100-proof liquor.

Study participants taking Topamax also had a higher rate of achieving 20 or more days of continuous abstinence and 28 or more days of continuous non-heavy drinking.

Side effects of the drug included abnormal skin sensations, distorted sense of taste, anorexia and difficulty with concentration.

Three drugs currently are approved in the U.S. to treat alcoholism. They include naltrexone, which interrupts the high of drinking, and disulfiram, which makes people sick when they drink. Forest Laboratories Inc. and Merck KGaA's Campral, approved in the U.S. in July 2004, helps reduce the physical and emotional discomfort felt in the weeks and months after a patient stops drinking, making abstinence from alcohol easier.

Willenbring with the National Institutes of Health said research in this area should yield more medications to treat alcoholism in the next five to 10 years. The institute is sponsoring about 33 clinical trials of drugs that have potential to treat alcoholism, he said.

``There are many other medicines that are in the pipeline,'' he said. ``It's a very exciting time.''

Public Citizen

Public Citizen, a Washington-based advocacy organization, said the study showed an increased incidence of dizziness, injury and difficulty concentrating among patients who consumed heavy amounts of alcohol while taking Topamax, the group said in a letter today to the Food and Drug Administration.

Sidney Wolfe, director of the Health Research Group at Public Citizen, urged the FDA to stop an ``illegal and dangerous promotional campaign'' that he said was tied to the Johnson & Johnson-sponsored study.

``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,'' Wolfe said in an e- mailed copy of the letter.

`Off-Label' Use

Johnson & Johnson said it won't support off-label use of its drug, which may lose some patent protection next year.

``We absolutely, positively don't support any reference to off-label use of our products,'' said Kara Russell, a spokeswoman for Johnson & Johnson's Ortho McNeil Neurologics division, in a telephone interview today. ``We only promote the use of Topamax for the approved indications of migraine prevention and epilepsy.''

Doctors in the U.S. are free to prescribe any medicine they feel would best treat a given condition, regardless of what the label says. Drugmakers are prohibited from promoting medicines for uses not approved by the Food and Drug Administration.

To contact the reporter on this story: Nicole Ostrow in New York at nostrow1@bloomberg.net.

Last Updated: October 9, 2007 18:52 EDT