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7/30/2004

FDA Approves Alcoholism Treatment

Kate Traynor

The Food and Drug Administration (FDA) yesterday announced the approval of acamprosate calcium delayed-release tablets for the treatment of alcohol dependency in patients who have completed withdrawal from alcohol.

Acamprosate is manufactured by Merck KGaA and will be marketed in the United States by Forest Laboratories Inc. under the brand name Campral. Forest announced that the product should be available near the end of this year. According to the announcement, acamprosate is currently sold in 28 countries other than the United States.

The FDA-approved labeling (PDF) for acamprosate is available at FDA's Web site.

Acamprosate is the first new treatment for alcohol dependency since 1994, when FDA approved naltrexone for this indication.

According to FDA, acamprosate is believed to act on neurotransmitter systems in the brain that have been altered by alcohol abuse, returning them to their normal state. The mechanism of action differs from the modes of naltrexone or disulfiram, the only other FDA-approved therapies for the treatment of alchohol dependency.

FDA stated that acamprosate should not be used by people who are drinking alcohol or abusing other substances at the start of treatment. The agency recommended that acamprosate be used in conjunction with "a comprehensive management program that includes psychosocial support."

In patients who have completed withdrawal from alcohol before starting treatment with acamprosate, FDA described the drug as well tolerated. Common adverse events reported in clinical trials included headache, diarrhea, and nausea.

Acamprosate is contraindicated in patients with severe renal impairment, according to the product's FDA-approved labeling.