The US FDA has approved Vivitrol (naltrexone for extended-release injectable suspension) for the treatment of alcohol dependence. Vivitrol, the first and only once-monthly injectable medication for alcohol dependence, is indicated for alcohol dependent patients who are able to abstain from drinking in an outpatient setting and are not actively drinking when initiating treatment. Treatment with Vivitrol should be used in combination with psychosocial support, such as counselling or group therapy, Alkermes, Inc., and Cephalon, Inc., announced here.

Alcohol dependence is a serious and chronic disease that affects multiple regions of the brain, providing rationale for the use of medication with psychosocial support as part of an integrated treatment plan. Of the more than 18 million Americans who abuse or are dependent on alcohol, approximately 2.2 million seek treatment for their alcohol problems. More than 75% of these patients relapse back to drinking within the first year of beginning treatment using currently available treatment approaches. A Vivitrol injection provides medication over one month, therefore, patients do not need to make a decision to take their medication every day.

"Vivitrol is the first once-a-month medication for alcohol dependence that ensures patients get the benefit of medication over the entire month," stated Richard Rosenthal, Chairman, Department of Psychiatry, St. Luke's-Roosevelt Hospital Centre, New York, and Professor of Clinical Psychiatry, Columbia University College of Physicians and Surgeons. "With Vivitrol, physicians have a new option to help treat patients with alcohol dependence, and patients have new hope to help them in their battle with this devastating disease," he added.

Cephalon and Alkermes expect Vivitrol to be available to physicians and patients in the United States by the end of June 2006. Vivitrol will be available as a single dose 380 mg intramuscular injection.

Based on a joint commercialization agreement signed in June 2005, Cephalon has primary responsibility for the marketing and sales of Vivitrol and Alkermes is responsible for manufacturing Vivitrol. Under the terms of the agreement, Alkermes receives a milestone payment of $110 million from Cephalon upon the FDA approval.