FDA approves Alkermes' opioid dependence treatment

Wed, 10/13/2010 - 8:34am
Mass High Tech: The Journal of New England Technology

The Alkermes Inc. medication Vivitrol has won approval by the U.S. Food and Drug Administration as a non-narcotic, non-addictive treatment for opioid dependence. The once-monthly treatment won approval from the FDA in 2006 to treat alcohol dependence.

In May, the company announced that its submission of Vivitrol for opioid dependence would receive an accelerated review from the FDA. The approval, according to a news release from Waltham-based Alkermes, stemmed from a six-month Phase 3 study in which Vivitrol met its primary efficacy endpoint and all secondary efficacy endpoints. The study showed higher rates of opioid-free drug screening in patients taking Vivitrol than in those taking placebo. Of its adverse effects, Vivitrol showed some instances of inflammed nasal passages, insomnia and raised levels of liver enzymes.



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