Alkermes says its anti-alcoholism drug met goal in late stage trial against opioid addiction

Alkermes’ Vivitrol succeeds in opiate study

CAMBRIDGE, Mass. — Alkermes Inc. said a late stage clinical trial shows its drug Vivitrol, which is used to help alcoholics quit drinking, also helped opioid addicts stay off drugs.

Subjects who were injected with Vivitrol once per month were more likely to pass a urine test than patients who received a placebo injection, Alkermes said. The drug also met secondary goals, as subjects reported a lower craving for drugs, and half of the subjects were clean in at least 90 percent of their drug tests.

The subjects were addicted to opioid drugs including heroin. Before participating in the trial, they had to stay off drugs for at least a week.

Vivitrol is an extended-release form of naltrexone. Alkermes said it will ask for approval to market Vivitrol for opioid addiction in the first half of 2010. In morning trading, its shares gained 15 cents to $8.06.

The trial included 250 patients. After the first month of the study, they took one urine test per week, and were also asked about their drug use. The study lasted six months.

The most common side effects were insomnia and inflammation of the nose and throat, Alkermes said.