), was effective even when taken by patients who were still drinking. Other alcoholism treatments are typically started only after the patient has quit, a difficult goal to attain.
Vivitrex is one of the first of a new generation of medicines for alcoholism, a disease that has been long been treated primarily by therapy or Alcoholics Anonymous-style 12-step programs (see BW, 4/11/05, "Can Alcoholism be Treated?"). Though not a cure, treatment specialists believe Vivitrex and other anti-alcoholism drugs can significantly help patients who can't overcome the physical dependency of their addiction (see "Your Brain on Alchohol"). Alkermes, based in Cambridge, Mass., filed an approval application for Vivitrex with the Food & Drug Administration on Apr. 1.
TOUGH PILL. The drug is a variation of the generic drug naltrexone, a daily pill that blocks opioid receptors in the brain that help to induce the feeling of euphoria brought on by drinking. Naltrexone was first approved for the treatment of heroin addiction in 1984. A decade later, the FDA cleared its use for alcohol addiction as well. But naltrexone was never widely used because it's difficult to get alcoholics to take a pill for their disease every day. Vivitrex is administered once a month by a doctor as an injection.
The Vivitrex trial, led by Dr. James Garbutt of the University of North Carolina at Chapel Hill, was one of the largest ever for an alcoholism drug. Researchers in 24 treatment centers across the U.S. gave Vivitrex or a placebo to 627 actively drinking adults for six months. Both groups also received 12 sessions of psychosocial intervention.
Compared with placebo, those patients on the highest doses of Vivitrex reduced their number of heavy drinking days by 25%, with heavy drinking defined as five or more drinks a day for men and four or more for women. Patients on a lower dose of Vivitrex cut their heavy drinking days by 17%. Overall, the study found that Vivitrex combined with therapy reduced the median number of patients' heavy-drinking days in a month from 19 to 3. The side effects were mild -- usually nausea, headache, and fatigue -- and decreased over time.
"NEW DOORS." Vivitrex follows on the heels of Campral, a Forest Laboratories (FRX
) pill, taken three times a day, that was approved by the FDA for alcoholism treatment last August. Both target one of the largest unmet needs in medicine. The World Health Organization estimates that alcoholism is the fourth leading cause of disability worldwide. In the U.S., it affects some 4% of the population and may contribute to as many as 100,000 preventable deaths each year.
"As we learn more about how the brain is affected by alcohol, we are discovering how best to provide treatment, like adding a safe medication to counseling," says Helen Pettinati of the University of Pennsylvania's Center for the Study of Addictions, and an investigator on the Vivitrex trial. "A long-acting injectable, which eliminated the burden of daily pill taking, will open new doors for our patients." It could also mark the beginning of new hope for at least some of the 180 million alcohol abusers in the U.S. Arnst is a senior writer for BusinessWeek in New York