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Drug cuts drinking in alcoholic men

Treatment cuts male alcohol consumption almost by half

NEW YORK, Dec. 8 — An experimental treatment for alcoholism reduced the rate of drinking in men by as much as 48 percent in a late-stage clinical trial but did not work in women, the drug maker said Monday.

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It is not clear why the drug works in men and not in women.

THE DRUG, Vivitrex, is a long-acting version of a generic drug already on the market called naltrexone. Unlike naltrexone, which is taken as a daily pill, a single injection of Vivitrex lasts for one month, apparently improving the rate of compliance in taking the medicine. Men taking 380 mg of Vivitrex reduced heavy drinking by about 48 percent compared with those taking a placebo. Heavy drinking is defined as five drinks a day in men and four drinks a day in women, Alkermes said. Men taking a lower dose of the drug, 190 mg, saw a 25 percent reduction in their drinking compared with those on a placebo. At both doses the results were statistically significant and met the main goals of the trial. Two-thirds of the patients in the Phase III study were male, which is representative of the alcoholic population, said Cambridge, Massachusetts-based Alkermes, which designed and paid for the trial, It is not clear why the drug works in men and not in women, though Gastfriend, a trial investigator, said it is possible that women may take longer to respond. He said that while the response in men was seen very early in the trial, responses in women were seen toward the end of the six months. He said there could also be an impact from genetic differences between men and women and between the social and psychological relationship between women and and men to drink. Women tend to become alcoholic later than men but their tissues are damaged earlier. They are more reluctant to seek treatment but once in it they are more successful, he said. Pops, Alkermes chief executive, said in an interview last week that if the data turned out to be positive, the company would expect to file for marketing approval in the first half of 2005. SIDE EFFECTS In the meantime, Alkermes plans, at the request of the U.S. Food and Drug Administration, to conduct additional safety studies. The most common side effects in the trial were nausea, headache and fatigue. Trials of naltrexone showed some liver toxicity and its label carries a major warning.

“Our plan is to not have that label,” Pops said. “Our clinical collaborators don’t believe there is a problem with toxicity and that the original trial was conducted only on a small number of patients who may already have had liver damage.” Pops said there was no evidence of liver toxicity in Alkermes’ trial of 624 patients. He said patients were not excluded from the trial based on the length of time they had been drinking, though the trial did exclude people with explicit liver damage. Gastfriend said the warnings of liver toxicity should be examined in the context of a disease that in itself can do significant harm to the liver. Vivitrex works by blocking a receptor in the brain that responds to the rush of certain endorphins that are excessively stimulated by alcohol in alcoholics. Endorphins are the body’s natural pain killers, and are responsible for certain feelings of euphoria such as the “runner’s high.” © 2003 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content is expressly prohibited without the prior written consent of Reuters.

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