Alkermes, Cephalon receive FDA approval of Vivitrol for treatment of alcohol dependence

By Lisa Kerner

Erie, Pa., April 13 - Alkermes, Inc. and Cephalon, Inc. said the Food and Drug Administration approved Vivitrol (naltrexone for extended-release injectable suspension) for the treatment of alcohol dependence. The companies expect the once-monthly injectable medication to be available as a single dose (380 mg) in the United States by the end of June.

Vivitrol works by binding to opioid receptors in the brain and is indicated for alcohol-dependent patients who are able to abstain from drinking in an outpatient setting and are not actively drinking when starting treatment, according to a company news release.

"Vivitrol is the first once-a-month medication for alcohol dependence that ensures patients get the benefit of medication over the entire month," Dr. Richard Rosenthal, chairman, Department of Psychiatry, St. Luke's-Roosevelt Hospital Center, New York, said in the release.

Of the more than 18 million Americans who abuse alcohol, about 2.2 million seek treatment. More than 75% of these patients relapse back to drinking within the first year using current treatments, the release stated.

Under the terms of a joint commercialization agreement, Cephalon has primary responsibility for the marketing and sales of Vivitrol. Alkermes is responsible for manufacturing Vivitrol and receives a milestone payment of $110 million from Cephalon upon the FDA approval.

The efficacy of Vivitrol was studied in a six-month phase 3 double-blind, placebo-controlled, randomized clinical trial of alcohol dependent patients with the primary endpoint being reduction in the rate of heavy drinking days.

The most common adverse events associated with Vivitrol were nausea, vomiting, headache, dizziness, fatigue and injection site reactions.

Alkermes is a pharmaceutical company that develops products based on drug delivery technologies to enhance therapeutic outcomes in major diseases. The company is located in Cambridge, Mass.

Based in Frazer, Pa., Cephalon discovers, develops and markets products in four core therapeutic areas: central nervous system, pain, oncology and addiction.

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