The National Institute on Alcohol Abuse and Alcoholism welcomes the U.S. Food and Drug Administration announcement of an indication for use of the pharmacologic agent naltrexone (REVIA tm) as a safe and effective adjunct to psychosocial treatments for alcoholism.
Naltrexone offers new hope for preventing relapse in many of the more than 1 million Americans treated each year for the disease. Of treated patients, approximately 50 percent relapse within the first few months of treatment.
"While not a 'magic bullet,' naltrexone promises to help many patients in their struggle against a chronic relapsing disease. Identification of this pharmacologic treatment builds momentum to elucidate the myriad, complex brain mechanisms of alcohol addiction," said NIAAA Director Enoch Gordis, M.D.
Separate NIAAA-supported, 3-month trials conducted by Joseph Volpicelli, M.D., Ph.D., and colleagues at the University of Pennsylvania and Stephanie O'Malley, Ph.D., and colleagues at Yale reported in 1992 that naltrexone helped to prevent early return to heavy drinking in a significant proportion of treated patients. In addition, patients who received naltrexone reported less alcohol craving and fewer drinking days than patients given a placebo.
Both NIAAA-supported studies were conducted in conjunction with psychosocial treatments.
A recently concluded 3-month trial by the DuPont Merck Pharmaceutical Company found that the drug was well tolerated at the recommended dose (50 mg/day) in a large, heterogeneous population of alcoholics in diverse treatment modalities and settings. DuPont Merck and the NIAAA investigators will present their data at a press briefing, to be held at 10:00 a.m. January 17 at the Hotel Macklowe in New York. For additional information about the press conference, contact Lindy Moran at (212) 966-4187.
The FDA considered data from both the NIAAA-supported studies and the Dupont Merck study in approving naltrexone as an adjunct to conventional treatments.
NIAAA currently supports nine additional clinical trials to determine the patient type, dose, therapy combinations, and treatment duration with which naltrexone works best.
"For now at least, only physicians familiar with addiction treatment probably should prescribe naltrexone, and only in the context of an alcoholism treatment program," said Dr. Richard K. Fuller, Director, Division of Clinical and Prevention Research at NIAAA.
Clinical judgment will dictate whether a patient should be started on conventional treatment or conventional treatment and naltrexone, Fuller suggested.
Although the FDA recommended no specific time period for naltrexone administration, safety and efficacy reports to date are from 3-month studies only.
Availability of this first pharmacologic treatment since disulfiram (ANTABUSE tm) marks a new era in alcoholism treatment. Introduced in 1948, disulfiram is an aversive agent that produces unpleasant symptoms in patients who drink.
Unlike disulfiram, naltrexone and other potential agents now under NIAAA investigation directly target hallmark features of alcoholism: abnormal alcohol-seeking behavior, impaired control over alcohol intake, and physiological dependence manifest in craving when alcohol is removed.
Naltrexone appears to reduce craving in abstinent patients and to block the reinforcing effects of alcohol in patients who drink. The latter effect lessens the likelihood that patients who drink a small amount of alcohol will return to heavy drinking. NIAAA is continuing neuroscience research to delineate the specific brain mechanisms involved in the reward and reinforcement associated with alcohol.
The approval of naltrexone culminates more than two decades of concerted NIAAA research on alcoholism, alcohol abuse, and alcohol-related problems. The Institute celebrates its 25th anniversary this year.
NIAAA is one of 17 institutes of the National Institutes of Health, a Public Health Service agency within the U.S. Department of Health and Human Services.