The United States Food and Drug Administration has approved Campral (acamprosate calcium) tablets which help recovering alcoholics to stay off the drink. Campral is manufactured by Forest Laboratories and Merck of Darmstadt, Germany.
Campral is expected to be available around the end of the year. Campral is the first new medication in nine years to be approved in the U.S. for the treatment of alcohol dependence.
The number of American adults who abuse alcohol or are alcohol dependent rose from 13.8 million (7.41 percent) in 1991-1992 to 17.6 million (8.46 percent) in 2001-2002, according to results from the 2001-2002 National Epidemiologic Survey on Alcohol and Related Conditions (NESARC), a study directed by the National Institute on Alcohol Abuse and Alcoholism (NIAAA).
WHO classifies alcoholism as a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance misuse and that typically include a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to its use than other activities and obligations, increased tolerance, and sometimes a physical withdrawal state.
"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.