) received Food & Drug Administration approval for Campral, a drug that helps recovering alcoholics stay on the wagon. Campral is no cure-all, but many doctors and researchers nonetheless applaud the approval as a small but significant step forward in the U.S.'s approach to treating alcohol addiction.
The U.S. is well behind other nations in using drugs to help battle alcoholism. Including Campral, only three anti-alcoholism drugs have earned FDA approval -- and Campral is the first new one in almost a decade. Moreover, fewer than 5% of the nation's 14 million alcoholics are being treated with drugs, with the vast majority relying on behavioral therapy and support groups like Alcoholics Anonymous to help them quit. Though alcoholism is increasingly viewed in the U.S. as a disease, the predominant belief is that "you don't treat a sin with medication," says A. Tom McLellan, professor of psychiatry at the University of Pennsylvania and director of the Treatment Research Institute, a nonprofit group that evaluates addiction therapies.
Many American alcoholics are starting to demand more help in achieving what for most is the greatest challenge: Long-term abstinence. One of the other two drugs, Antabuse, made by privately held Odyssey Pharmaceuticals in East Hanover, N.J., is typically given to people in the initial detox phase of sobering up. The drug, which causes patients to vomit when they try to drink, has nasty side effects and isn't practical for recovering alcoholics over the long term.
FEW SIDE EFFECTS. The other approved drug, Naltrexone, which is now a generic sold by various manufacturers, is more practical for long-term use: It seems to block the "high" achieved from drinking. The hope is that Campral, perhaps in combination with Naltrexone, could give alcoholics significant help in staying sober.
Campral plays a different role in the brain than the other two drugs. It's believed to help bring a hyperactive glutamate system back to normal levels and dull the intensity of withdrawal. Researchers believe that overactive glutamate -- a neurotransmitter involved in memory and learning -- contributes to the physical symptoms of withdrawal. "A drug to complement the motivation to quit is really interesting," says Jennifer Potter, research psychologist at Harvard Medical School and McLean Hospital in Belmont, Mass. "Even if it has only a small benefit, it's important to take a look at it."
Still, Campral's benefits don't appear to be earth-shattering. In a recently completed U.S. study of the drug headed up by Barbara Mason, researcher at the Scripps Research Institute, patients who used Campral in conjunction with behavioral therapy were abstinent about 10% to 15% longer than those receiving counseling and a placebo. There were no deaths or serious adverse events during the six-month, 601-patient study. And the most common side effect of the drug was mild diarrhea at the start of treatment. Mason submitted the study for journal publication in August.
CONTINENTAL RESULTS. Researchers are also wrapping up a large, multicenter trial of Campral, Naltrexone, and both drugs combined. That study, for which 1,380 patients took the drugs in conjunction with various behavioral therapies as well as without any additional therapy, should help elucidate what combination of therapies works best. Data from the study, which was funded by the National Institutes of Alcohol Abuse & Alcoholism in Bethesda, will be available in the fall of 2005, says Raye Litten, co-team leader for medications development team at the NIAAA's division of treatment and recovery research.
Campral has already fared well in Europe, where it has been available since 1989 and is mainly used to prevent relapses. The drug has been studied in 15 controlled clinical trials. Potter notes that all but two of the trials showed Campral to be more effective than a comparison treatment or placebo. McLellan figures the drug helps about one-third of alcoholics.
For Forest, Campral probably won't be a blockbuster. Forest licensed rights to sell the drug in the U.S. from Merck Kgaa, a German drugmaker unconnected to the U.S. drug company Merck (MRK
). Wall Street analysts believe it will provide only an incremental boost to the company's annual revenues, which hit $2.7 billion in fiscal year ended March, 2004, and are projected to expand to $3.1 billion in the current fiscal year. A.G. Edwards analyst Al Rauch figures Campral will bring in between $25 million and $75 million in annual revenues for the company.
The company says it has no plans to run Campral commercials aimed at the general public. Some 400 Forest salespeople will be out promoting the drug to psychiatrists in the coming months, but all marketing and promotion will be geared toward physicians and addiction-treatment centers, says Ken Goodman, Forest's president and chief operating officer. "The drug is meant for patients who are in some kind of program of psychosocial counseling." For some of them, it may be just the edge they need to stay off the sauce for good. Tsao covers the markets for BusinessWeek Online