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Campral (Acamprosate Calcium) Appears Safe, Well-Tolerated in Long-Term Treatment of Alcohol Dependence

DALLAS, TX -- April 15, 2005 -- Forest Laboratories, Inc. (NYSE: FRX) today announced results of two analyses of several studies demonstrating that CampralŪ (acamprosate calcium) Delayed-Release Tablets is safe and well-tolerated in the long-term treatment of alcohol dependence. The report(1), which was presented today at the 36th Annual Medical-Scientific Conference of the American Society of Addiction Medicine (ASAM), found Campral to be safe and well tolerated in studies up to one year, even in patients taking other drugs such as antidepressants and analgesics.(1)

"These data are important because they show that Campral is safe for alcohol-dependent patients and even in those who may be taking other medications," said investigator Richard N. Rosenthal, MD, Professor of Clinical Psychiatry, Columbia University College of Physicians and Surgeons. "Unlike older treatments for alcohol dependence, Campral is not metabolized through the liver. Its favorable long-term safety profile makes it an attractive new option to help reduce relapse in patients committed to staying abstinent from alcohol."

The abstract "Acamprosate is Safe and Well-Tolerated in the Long-Term Treatment of Alcohol Dependence" received this year's ASAM Medical-Scientific Program Committee Award for having the highest rating for scientific merit. The ASAM Conference Program Committee reviewers grant this award to one abstract each year. The award is based on the presentation of new ideas or findings of importance to the field of addiction medicine, the methodology used and clarity of presentation.

Results

The abstract contained data from two key analyses. The first analysis assessed five year-long, double-blind, placebo-controlled studies (n=1681) to determine long-term safety and tolerability of Campral in alcohol-dependent patients, 16 to 70 years of age.(1) 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 (n=3395). The aim of this second analysis was to evaluate the impact of concomitant medications on the tolerability profile of Campral versus placebo.

In the first analysis, the overall incidence of spontaneously reported adverse events was similar between the Campral 1998 mg/day group and the placebo group.(1) Rates of adverse events for the combined Campral group (1998 mg and 1332 mg) were higher than placebo (59 percent vs 52 percent; P<0.050).(1) Diarrhea was the only adverse event reported at higher rates than placebo, occurring in 10 percent of both Campral groups and 6 percent of the placebo group (P<0.010).(1) The 1998 mg dose is the only dose approved by the FDA.(2) In the second analysis, the incidence of adverse events in patients treated with Campral concomitantly with medications such as antidepressants, anxiolytics, sedatives, hypnotics, and analgesics, was comparable to that of patients taking placebo with these concomitant medications.(1) Overall, in this study, Campral was found to be safe and well-tolerated in the long-term treatment of alcohol dependence.(1)

About Campral

Campral (acamprosate calcium) Delayed-Release Tablets are FDA-approved for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation.(2) Treatment with Campral should be part of a comprehensive management program that includes psychosocial support.(2) In clinical trials, patients taking Campral demonstrated a higher rate of complete abstinence, longer time to first drink, and greater percent days abstinent than those taking placebo.(1) The mechanism of action of Campral in maintenance of alcohol abstinence is not completely understood. It is believed to restore the normal chemical balance in the brain, which is disrupted by chronic heavy drinking.(2)

In the clinical trial program, side effects for Campral were generally mild with the most frequently reported side effect being diarrhea.(2) Campral is contraindicated in patients with severe renal impairment (creatinine clearance less than or equal to 30 mL/min) and requires a dose reduction in patients with moderate renal impairment (creatinine clearance of 30-50 mL/min).(2)

The recommended dose of Campral is two 333 mg tablets taken three times daily (1998 mg total daily dose). Treatment with Campral should be initiated as soon as possible after the period of alcohol withdrawal, when the patient has achieved abstinence, and should be maintained if the patient relapses.(2) Campral was developed by Merck Sante s.a.s., subsidiary of Merck KGaA of Darmstadt, Germany, and licensed to Forest Laboratories for the United States. Interested parties can get more information on Campral and obtain the prescribing information by visiting http://www.campral.com or by calling 800-678-1605.



References:

(1) Rosenthal, Richard N. "Acamprosate is Safe and Well-Tolerated in the Long-Term Treatment of Alcohol Dependence." Abstract submitted to American Society of Addiction Medicine, 2005 Medical-Scientific Conference, October 1, 2004.

(2) CAMPRAL(R) Delayed-Release Tablets Prescribing Information, Forest Laboratories, Inc., St. Louis, MO, 2004, p. 4.

SOURCE: Forest Laboratories

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