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FDA Approves Campral (Acamprosate) for Treatment of Alcohol Dependency

NEW YORK, NY -- July 30, 2004 -- Forest Laboratories, Inc. (NYSE: FRX) and Merck KGaA (Merck) of Darmstadt, Germany, announced that the United States Food and Drug Administration (FDA) has approved CampralŪ (acamprosate calcium) Delayed-Release Tablets for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. Treatment with Campral should be part of a comprehensive management program that includes psychosocial support.

Forest expects Campral to be available to physicians, patients and pharmacies around the end of the year. Developed by Merck, Campral is the first new medication in nine years to be approved in the U.S. for the treatment of alcohol dependence, a chronic disease that accounts for approximately 100,000 deaths per year.(1) Nearly 14 million Americans have a problem associated with alcohol.

"The approval of Campral offers a new therapeutic option for alcohol-dependent patients in the United States, which we hope will enable more patients to successfully control this complex and chronic disease," said Howard Solomon, Chairman and Chief Executive Officer of Forest Laboratories, Inc.

Campral was licensed to Forest in 2001. Under terms of the licensing agreement, Forest is responsible for sales and marketing activities of the product in the U.S.; Merck will manufacture and supply the product. Forest will promote Campral to key healthcare providers, focusing on treatment centers, addiction specialists and physicians most experienced with the medical management of alcoholism.


About Campral

The mechanism of action of Campral in maintenance of alcohol abstinence is not completely understood. Chronic alcohol exposure is hypothesized to alter the normal balance between neuronal excitation and inhibition. Campral interacts with neurotransmitter systems and is hypothesized to restore the normal balance. This mechanism of action is different from that ascribed to currently available medications, which either block the "high" associated with alcohol or induce vomiting if alcohol is ingested. FDA approval of Campral is based primarily on the Agency's review of safety and efficacy data from four double-blind, placebo-controlled trials. In three of these trials, Campral increased abstinence rates when used as part of a multidisciplinary approach that included various types of psychosocial support. In a fourth study, the Campral-treated group failed to show a difference on the primary efficacy endpoint, cumulative abstinence duration. In the latter trial, patients were not required to be abstinent prior to randomization as required in the positive studies. In the clinical trial program, side effects for Campral were generally mild with the most frequently reported side effect being diarrhea.

Campral is also approved and available in 28 countries outside the United States.


(a) BenicarŪ is a registered trademark of Sankyo Pharma, Inc.


Reference:

(1) Garbutt JC., et al. Pharmacological Treatment of Alcohol Dependence. JAMA 1999; 281:1318-1325


SOURCE: Forest Laboratories, Inc.

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