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news.Alkermes' Vivitrol (naltrexone for extended-release injectable suspension), used for the prevention of relapse to opioid dependence, following opioid detoxification, has received approval from the US Food and Drug Administration (FDA).
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Alkermes claimed that Vivitrol is a non-narcotic, non-addictive, once-monthly medication approved for the treatment of opioid dependence.
The FDA approval of Vivitrol for the prevention of relapse to opioid dependence was based on data from a six-month, multi-center, randomised Phase 3 study which met its primary efficacy endpoint and all secondary efficacy endpoints.
In 2006, Vivitrol received approval for the treatment of alcohol dependence and should be used as part of a comprehensive management program that includes psychosocial support.
Alkermes CEO Richard Pops said that they believe that Vivitrol offers physicians and their patients a whole new approach, as the only long-acting, non-addictive treatment for opioid dependence.