Campral, first new treatment for alcoholism in ten years

Jan 12 2005

Forest Laboratories announced that Campral (acamprosate calcium) Delayed- Release Tablets are now available to physicians, patients and pharmacies nationwide.

Campral was approved by the U.S. Food and Drug Administration (FDA) on July 29, 2004 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. The approval of Campral was the first in nearly ten years of a treatment for alcohol dependence.

"We believe that Campral, in combination with psychosocial support, sets a new standard for treating the chronic disease of alcoholism," said Howard Solomon, Chairman and Chief Executive Officer of Forest Laboratories. "Forest is committed to providing an effective and safe drug therapy to help the millions of Americans struggling with alcohol-dependence to maintain abstinence."

"A major treatment goal for alcohol dependence is to increase rates of abstinence," said Barbara Mason, Ph.D., Professor of Neuropharmacology, Co- Director of The Pearson Center for Alcoholism and Addiction Research, The Scripps Research Institute. "Campral, when used in combination with psychosocial support, can help committed patients reach this goal because it is thought to help restore the brain's chemical balance that has been disrupted by long-term excessive drinking."

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 short and long-term efficacy and safety data from double-blind, placebo-controlled trials. In three of the trials, which lasted from 90 days to 360 days, Campral plus psychosocial therapy proved superior to placebo plus psychosocial therapy in maintaining abstinence, as indicated by a greater percentage of subjects being assessed as continuously abstinent throughout treatment.

In a fourth study, the Campral-treated group failed to show a difference on the primary efficacy endpoint, cumulative abstinence duration. In this 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.(4) 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).

The recommended dose of Campral is two 333 mg tablets taken three times daily. 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.

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.