Migraine Drug May Treat Alcoholism, Too

Oct. 9, 2007— -- Topiramate, a drug currently used to treat migraines and seizures, may also help those with alcohol dependence.

But whether it will be used in clinical practice is another question.

A new study appearing in the current issue of the Journal of the American Medical Association finds that the drug, commonly known by the brand name Topamax, can reduce alcohol dependence and the number of days alcoholics drink heavily.

However, drugs like topiramate are not widely prescribed, and the company that manufactures Topamax, Ortho-McNeil Neurologics Inc., says it does not plan to market the drug as a treatment for alcoholism.

Still, some hope that the finding may help some who struggle with alcohol dependence.

"I think it offers a new hope for patients," says lead study author Dr. Bankole Johnson, chairman of the department of psychiatric medicine at the University of Virginia Health System. "It offers a hope that patients can get immediate treatment, and it reinforces the fact that alcoholism is a brain disorder and can be treated with medications."

Migraine Drug a Big Headache

However, getting a drug approved by the U.S. Food and Drug Administration is no easy task; the cost and time involved are enormous.

"The regulatory requirements and documentation are very time consuming," says Dr. James Garbutt, a professor of psychiatry at the University of North Carolina at Chapel Hill. "The detail is mind-boggling, and it costs a fortune, many millions of dollars, to prove and confirm the data, compile it and present it to the FDA."

Additionally, the company says that Topamax will not be marketed for alcohol dependence, because its researchers were unable to alleviate the side effects associated with the drug. The company had hoped, for example, that it could develop a pill to release the drug slowly into the blood, thereby reducing such side effects as difficulty concentrating, prickling of the skin and sleepiness.

"We were developing a controlled release formulation to achieve more even blood levels of Topamax in hopes of improving the side effects," says Joseph Hulihan, vice president of medical affairs at Ortho-McNeil Janssen Scientific Affairs. "However, when the controlled release formulation did not improve side effects, we didn't move forward with it, and we didn't move forward with our other initiatives either, such as marketing it as a treatment for alcohol dependence."

An Off-Label Option?

But since the drug has already been approved for treatment of migraines and seizures, physicians can prescribe it as an off-label drug if additional studies confirm the findings.

Ortho-McNeil told ABCNEWS.com that it only promotes Topamax for its approved uses and has distanced itself from the idea of off-label scripts for the pill.

Still, doctors may look to it as an off-label alcoholism treatment option.

"The company may not go through all the paperwork and expense to market the drug, but physicians are free to prescribe it, because it has already been approved by the FDA," explains Garbutt.

And many doctors may welcome an additional tool against alcoholism — a condition characterized by an obsession with alcohol and an inability to control drinking habits. People who suffer from it often deny they have a drinking problem, which makes treatment difficult.

"Alcoholism is a hidden disease," says Garbutt. "Only about 25 percent of alcoholics ever get treatment. Patients who are addicted don't want to change. Physicians don't ask and patients don't tell, which is why so many go untreated."

Dr. Mark Willenbring, at the National Institute on Alcohol Abuse and Alcoholism, agrees that alcoholism is undertreated and says that the problem needs to be addressed by physicians.

"One potential solution is for primary care physicians and psychiatrists to begin systematically identifying and treating alcohol dependence in their patients," Willenbring writes in an editorial accompanying the study.

"Unfortunately, physicians receive minimal education in this area, being exposed primarily to hospitalized, severely ill patients with alcoholism," he continues. "Consequently, many clinicians may feel ill-equipped to care for patients with alcohol disorders, except to refer to specialty treatment."

And of those who do get treatment, only a very small number — 10 percent — receive medications. Currently, there are three drugs approved by the FDA to treat alcohol dependence: Anabuse, Naltrexone and Campral, but they are not widely used.

"It has been a great disappointment," says Garbutt. "There is a lack of understanding in both patients and physicians. We need to get the word out that there are medications that can help."

And unlike the current medications available, topiramate can be given to patients seeking immediate treatment.

"Current drugs are for relapse prevention," says Johnson. "Patients have to stop drinking before they can be put on the drugs. Topamax can be given immediately, at the time of crisis. It helps people reduce the number of heavy drinking days, and it prevents relapse — a dual action."

The drug may be able to treat other addictions as well. "We are just finishing up a trial for the National Institutes of Health, looking at Topamax as a possible treatment for methamphetamine addiction," says Johnson. "There is also preliminary evidence that it could reduce smoking and cocaine use."

Not a Cure-All

However, topiramate will not necessarily be the new cure for addictions. It has the potential to work well for some patients but not for others, because different people have different brain chemistry — which means that, for some patients, existing drugs may be best.

"The comparison of Topamax with Campral and Naltrexone should not be viewed as a competition for treatment of the same patient," says Boris Tabakoff, a professor of pharmacology at the University of Colorado's school of medicine.

He explains that personalized medicine — matching specific patients to specific medications — may be available in the near future.

"It has already been demonstrated that significant differences in patient characteristics distinguish success from failure," Tabakoff says. "In essence, the three medications may, in fact, be each more effective in particular subpopulations of excessive drinkers."

Garbutt also agrees that topiramate could help a specific group of people.

"Because Topamax has a different mechanism of action, it may be helpful for patients who do not respond to other medications," he explains.

And medication is only one component of the toolbox for treating alcoholism. Counseling, peer support and family encouragement can also play a major role in helping someone overcome alcohol addiction.