FDA approves Vivitrol for alcohol dependency

USA-based firms Alkermes and Cephalon say that the Food and Drug Administration has approved their co-developed drug Vivitrol (naltrexone for extended-release injectable suspension) for the treatment of alcohol dependance. The drug mediates its effects via interaction with opioid receptors in the brain, in a mechanism which is not yet fully understood.

The approval is based on data from a six-month Phase III, double-blind, placebo controlled trial of the drug in the treatment of alcohol dependant patients, which showed that monthly treatment with a 380mg dose of the compound reduced heavy drinking, in combination with counselling, to a greater extent than placebo and counselling alone.

The two companies submitted a New Drug Application seeking approval for this indication last year (Marketletter April 11, 2005). The approval triggers a $110.0 million milestone payment to Alkermes, as stipulated under the terms of their 2005 agreement.