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Campral Is Safe, Well-Tolerated in Treatment of Alcohol Dependence

April 18, 2005

Forest Laboratories has announced results of two analyses of several studies demonstrating that Campral delayed-release tablets are safe and well-tolerated in the long-term treatment of alcohol dependence.

The analyses found Campral (acamprosate calcium) to be safe and well-tolerated in studies up to one year, even in patients taking other drugs such as antidepressants and analgesics.

The first analysis assessed five year-long, double-blind, placebo-controlled studies to determine long-term safety and tolerability of Campral in alcohol-dependent patients, 16 to 70 years of age. In this five-study analysis, patients were randomized to receive either Campral 1332 mg/day or Campral 1998 mg/day with counseling, or placebo plus counseling.

A second analysis reviewed four long-term studies and six short-term studies. The aim of this second analysis was to evaluate the impact of concomitant medications on the tolerability profile of Campral versus placebo.