Alkermes Inc. (ALKS) received a boost when the US Food and Drug Administration (FDA) cleared its drug Vivitrol (naltrexone for extended-release injectable suspension) for the prevention of relapse to opioid dependence after opioid detoxification. Opioid dependence refers to a chronic ailment of the brain.
The approval of Vivitrol, already available for the treatment of alcohol dependence for which it gained FDA approval in 2006, for the additional indication does not surprise us. Last month, an advisory panel of the FDA had recommended the approval of Vivitrol for treating opioid dependence. The FDA’s Psychopharmacologic Drugs Advisory Committee voted 12-1 in favor of approving Vivitrol for the additional indication.
We remind investors that the supplemental New Drug Application (sNDA), seeking to expand Vivitrol’s label, was submitted in April 2010. The application was based on positive results from a randomized, multi-center, late-stage six month study which evaluated the efficacy and safety of Vivitrol for opioid dependence.
We believe that the approval of Vivitrol for the additional indication will help boost its sales. Following the approval, Vivitrol becomes the first and only non-narcotic, non-addictive, once-monthly therapy for treating opioid dependence.
Apart from Vivitrol, the FDA is scheduled to decide on another Alkermes drug in October this year. The target date for Bydureon, co-developed by Alkermes, Eli Lilly (LLY) and Amylin Pharmaceuticals Inc. (AMLN) for treating type II diabetes, is October 22, 2010. We believe that if Bydureon is also approved by the US regulatory body then it would be a huge boost to Alkermes which should drive it towards profitability.
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