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FDA Approves New Drug for Treatment of Alcoholism

ROCKVILLE, MD -- July 30, 2004 -- FDA today approved the drug Campral (acamprosate), for treating alcohol dependent individuals seeking to continue to remain alcohol-free after they have stopped drinking. Campral may not be effective in patients who are actively drinking at the start of treatment, or in patients who abuse other substances in addition to alcohol.

Campral is the first new drug approved for alcohol abuse in a decade.

Alcoholism, or alcohol dependence, is a disease. The consequences of alcohol misuse are serious and in many cases, life threatening. Heavy drinking can increase the risk for certain cancers, especially those of the liver, esophagus, throat, and larynx (voice box). Heavy drinking can also cause liver cirrhosis, immune system problems, brain damage, and harm to the fetus during pregnancy. Chronic alcoholism continues to be a widespread and debilitating disorder that places a tremendous burden on society in terms of healthcare costs, lost wages and personal suffering.

While its mechanism of action is not fully understood, Campral is thought to act on the brain pathways related to alcohol abuse. Campral was demonstrated to be safe and effective by multiple placebo-controlled clinical studies involving alcohol-dependent patients who had already been withdrawn from alcohol, (i.e., detoxified). Campral proved superior to placebo in maintaining abstinence (keeping patients off alcohol consumption), as indicated by a greater percentage of acamprosate-treated subjects being assessed as continuously abstinent throughout treatment. Campral is not addicting and was generally well-tolerated in clinical trials. The most common adverse events reported for patients taking Campral included headache, diarrhea, flatulence, and nausea.

Treatment with Campral should be part of a comprehensive management program that includes psychosocial support.

The sponsor of Campral is Lipha Pharmaceuticals, Inc. in Lyon, France.

Source: The Food and Drug Administration

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