CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alkermes, Inc. (NASDAQ: ALKS) today announced that it has completed patient enrollment for the registration study of VIVITROL® (naltrexone for extended-release injectable suspension) for the treatment of opioid dependence, a chronic brain disease. The data from this study will form the basis of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for VIVITROL for this indication. VIVITROL is a once-monthly, intramuscular injection approved in the U.S. and Russia for the treatment of alcohol dependence and is not currently approved for the treatment of opioid dependence. Alkermes expects to report topline results from this registration study in late calendar 2009 and anticipates a sNDA submission in calendar 2010.
