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Campral approved for alcohol dependence

The Food and Drug Administration recently approved Campralâ (acamprosate) to help maintain abstinence from alcohol in persons who are alcohol dependent. Acamprosate is already marketed in 28 other countries. In the United States, approximately 14 million people have an alcohol problem, and alcohol abuse is linked with approximately 100.000 deaths annually. Alcohol dependence can have serious health consequences. For example, among other problems, chronic abuse can cause liver cirrhosis, suppression of the immune system, or lead to liver, throat, esophageal, or other cancers. Alcohol dependence also adversely affects society as a whole in terms of lost wages and overall healthcare expenditures.

To see a beneficial effect from acamprosate, individuals must be abstinent from alcohol when they begin treatment with the medication, and it should not be used in any patients who are concurrently abusing any other substance. In addition, effective treatment should include psychosocial support. Acamprosate was shown to improve rates of abstinence when combined with psychosocial support in three double-blind, placebo-controlled trials. For the same outcome, a fourth study found no difference between acamprosate and placebo, but these patients were not receiving any type of psychosocial support. In all four trials, acamprosate exhibited no potential for addiction, and the treatment was well tolerated. Frequently occurring adverse effects included diarrhea, headache, nausea, and flatulence.

The mechanism of action of acamprosate has not been fully elucidated, but it is believed to reestablish balance between neuronal inhibition and excitation that has been altered by alcohol abuse. This mechanism represents a novel approach to treatment of this disease. Medications already marketed for alcohol dependence either cause vomiting when patients drink alcohol or blunt the pleasant effects that occur with alcohol intoxication.

For the United States, Merck KGaA of Germany will manufacture and supply acamprosate while Forest Laboratories, Inc. will handle the marketing aspects of the product.

References:

1) FDA Talk Paper, July 29, 2004.

2) Press Release from Forest Laboratories, Inc., July 29, 2004.