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FDA panel backs Vivitrol for opioid dependence

September 17, 2010 12:32 AM UTC

FDA's Psychopharmacologic Drugs Advisory Committee voted 12-1 to recommend approval of an sNDA from Alkermes Inc. (NASDAQ:ALKS) to extend the label for Vivitrol naltrexone to prevent relapse to opioid use in opioid-dependent patients. The panel voted 11-2 that data from a single Russian Phase III trial was sufficient to conclude the drug is effective for the indication, and 10-1, with two abstentions, that the results were applicable for use in the U.S. population. The committee also voted 12-0, with one abstention, that the safety data for Vivitrol was adequate. ...