Drug approved to treat alcoholism - use of Revia approved by the Food and Drug Administration - Brief Article

FDA Consumer, April, 1995

The first new drug for treating alcoholism and alcohol abuse since 1948 was approved last Jan. 16 by FDA.

Revia (naltrexone hydrochloride) is an opioid-receptor antagonist previously approved to treat narcotic dependence.

When used in conjunction with a comprehensive treatment plan, Revia increases abstinence and reduces alcohol craving, according to two 12-week double-blind, placebo-controlled studies sponsored by the National Institute of Alcohol Abuse and Alcoholism (NIAAA).

In one study of 70 alcohol-dependent men, only 23 percent of those treated with Revia relapsed, compared with 54 percent of placebo-treated patients. Of patients who drank during the study, 50 percent of Revia-treated patients returned to heavy drinking, compared with 95 percent of placebo-treated patients.

In the other study of 104 alcohol-dependent men and women, Revia-treated patients were approximately twice as successful in abstaining and avoiding relapse as placebo-treated patients.

Revia is not habit forming and is not a drug of abuse. The most common side effect is nausea, usually mild and temporary. Other adverse reactions include difficulty sleeping, anxiety, nervousness, abdominal pain [or cramps], low energy, joint and muscle pain, and headache. Revia can cause liver toxicity when given at higher-than-recommended doses. It should not be given to patients who have abused narcotics within 7 to 10 days.

Alcoholism, or alcohol dependence, is a disease characterized by abnormal alcohol-seeking behavior and impaired control over drinking. Alcohol abuse is a pattern of problem drinking, short of dependence, that creates health, economic, social, or other problems for the drinker.

The only other drug approved for treating alcoholism is Antabuse (disulfiram). It works by causing nausea and vomiting when patients drink alcohol during treatment.

Revia is manufactured by DuPont Merck Pharmaceutical Co. and marketed by DuPont Pharma.