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TOPAMAX

Migrane Drug Helps Alcoholics Taper Off

A migraine pill seems to help alcoholics taper off their drinking without detox treatment, offering a potential option for a hard-to-treat problem. Unlike other drugs to treat alcoholism, topiramate, or Topamax, does not require people to stop drinking before starting treatment, the study's authors write in the Journal of the American Medical Association.

Experts said the drug is likely to appeal to heavy drinkers who would rather seek help from their own doctors rather than enter a rehab clinic to dry out. The drug costs $350 a month, plus the price of doctor-office visits.

"This is a drug that can be given to people in crisis," says lead author Bankole Johnson, psychiatry chair at the University of Virginia.

The drug works by inhibiting dopamine, the brain's feel-good neurotransmitters.

At the beginning of the study, participants in both groups reported drinking heavily an average of about 82% of days. By the last week, the topiramate group reported drinking heavily on 44% of days, compared with 52% of days for the placebo group. Topiramate users also were more likely to achieve 28 days of continuous non-heavy drinking or abstinence.

Some adverse events were about five times more common in topiramate users than in the placebo group. They included tingling of arms and legs, reported by half of topiramate users; strange tastes, reported by nearly a quarter on the drug; loss of appetite, reported by about a fifth of the topiramate patients; and difficulty with concentration in about 15% on the drug.

One patient advocate says he was not impressed by the "modest" improvement in topiramate users. "Both groups were still drinking quite heavily by the end of the study," Sidney Wolfe, director of the Public Citizen Health Research Group, wrote  to Food and Drug Administration Commissioner Andrew von Eschenbach.

Wolfe's letter raised concerns that a press kit about the study from the University of Virginia promoted off-label use of topiramate for treating alcoholism, even though the drug's labeling states users should avoid drinking alcohol. The press kit says doctors can prescribe topiramate off-label for treating alcoholism, Wolfe says.

In a statement, UVA spokeswoman Mary Jane Gore said, "No off-label drug use is being proposed, advocated or promoted."

Joe Hulihan, Ortho-McNeil Neurologics vice president for medical affairs, says the company has no plans to seek FDA approval to market Topamax to treat alcoholism.