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Alkermes Gets FDA Approval Of VIVITROL To Avert Relapse To Opioid Dependence

Alkermes Inc. (ALKS) Tuesday said that the U.S. Food and Drug Administration has approved VIVITROL, naltrexone for extended-release injectable suspension, for the prevention of relapse to opioid dependence, following opioid detoxification.

According to the company, VIVITROL is now the first and only non-narcotic, non-addictive, once-monthly medication approved for the treatment of opioid dependence. VIVITROL was approved by the FDA in 2006 for the treatment of alcohol dependence.

The company noted that the FDA approval of VIVITROL for the prevention of relapse to opioid dependence was based on data from a six-month, multi-center, randomized phase 3 study which met its primary efficacy endpoint and all secondary efficacy endpoints.

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