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FDA panel backs new use for drug

Associated Press / September 17, 2010

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NEW YORK — A panel of experts that is advising the Food and Drug Administration voted yesterday to recommend approval for Alkermes Inc.’s drug Vivitrol as a treatment for addiction to opioid drugs.

Vivitrol is an extended-release injection given once per month. It is already approved as a treatment for alcoholism.

The FDA’s Psychopharmacologic Drugs Advisory Committee voted 12-1 in favor of approving the drug for the new use. The agency is not required to follow the advice of its advisory panels, but it frequently does. The FDA is scheduled to make a binding decision on the drug by Oct. 12.

The recommendation underscores the need for new treatments, said Richard Pops, chief executive of Alkermes.

Shares of Cambridge-based Alkermes were not traded on Wall Street yesterday. On Wednesday, they closed at $14.22.