FDA Approves New Treatment for Alcoholism
July 30, 2004
WASHINGTON (AP) - The government approved the first new drug to treat alcohol abuse in a decade on Thursday, a medicine called Campral that promises to help ward off relapses.
Campral, known chemically as acamprosate, isn't for patients who are actively drinking at the start of treatment or who abuse other substances in addition to alcohol, the Food and Drug Administration warned.
Exactly how Campral works isn't fully understood. But it is thought to somehow ease alcoholism withdrawal symptoms by normalizing abnormalities in two brain chemical systems.
In a study comparing Campral to a dummy pill, more of the people using Campral were continuously abstinent throughout their alcohol-abuse treatment, FDA said - although officials late Thursday couldn't provide the numbers to show how big the difference was.
Most common side effects were headache, diarrhea, flatulence and nausea, FDA said.
Campral, made by France's Lipha Pharmaceuticals, has been widely used in Europe for years. In the United States, there are two other FDA-approved drugs for alcohol abuse treatment: Antabuse, which reacts with alcohol to make the drinker violently ill, and naltrexone, which blocks brains chemicals that make alcoholics feel good after a drink.
Campral will be distributed in the United States by Forest Laboratories, which did not immediately reveal a price.