Acamprosate - No Magic BulletFDA Panel Says Drug Can Be Effective for Some A Federal Drug Administration review panel has ruled a drug used in Europe for 15 years to treat alcoholism effective but it's still no magic bullet that will keep alcoholics sober.
Acamprosate, which is manufactured by a German company, has been tested by researchers in Europe and the United States with varying results. Last week, an advisory panel voted 8-2 to recommend the drug to the FDA as "effective." It has not yet been approved for use in the United States, because safety tests for side effects are not yet complete.
"We clearly seem to have evidence that it's an effective medicine for abstinence," panelist Irene Ortiz of the Veterans Administration Medical Center in Albuquerque, NM told reporters.
But how effective is it?
For those who want total abstinence, acamprosate "looks promising, but it's not a blockbuster," FDA medical reviewer Dr. Celia Jaffe Winchell told Reuters.
The panel reviewed three European trials and one in the United States in which recovering alcoholics were given either acamprosate or a placebo. The drug kept more alcoholics from drinking in the three European trials, but it did not "meet the main effectiveness goals" in the more recent U.S. study, FDA officials said.
In the European trials, 62 percent of those taking the drug remained abstinent for a year, while in the United States only 46 percent stayed sober for a year. In all trials, for those who did not quit drinking, the drug reduced the number of days they drank during the year.
No Magic BulletThe panel said results may have been worse in the United States because most U.S patients were addicted to multiple drugs and only a third went through detoxification before starting acamprosate or a placebo. All of the European subjects went through detox before trying acamprosate and were "motivated to quit."
Currently only two drugs are approved in the U.S. for treatment of alcoholism -- Bristol-Myers Squibb Co.'s naltrexone and Wyeth's Antabuse. Addiction specialists say neither is always effective or appropriate.
Acamprosate is made by Germany's Merck KGaA, which is not related to U.S. drug giant Merck and Co. Inc. Approved in 39 other countries, acamprosate would be marketed in the United States by Forest Laboratories Inc.
"We acknowledge that acamprosate is not the magic bullet we all seek," said Anita Goodman, executive vice president of Merck/Lipha Pharmaceuticals. "However, the overall picture is indeed clear enough."