Recently Alkermes, Inc. (ALKS) submitted a supplemental New Drug Application (sNDA) for Vivitrol (naltrexone for extended-release injectable suspension) to the US Food and Drug Administration (FDA) for treating opioid dependence. Opioid dependence refers to a chronic ailment of the brain. The affected individual continues to use opioids despite the damage caused by it.
Vivitrol, an injectable opioid antagonist administered once-monthly, is already available as an injectable medication for alcohol dependence. The drug received FDA approval in 2006. Vivitrol was initially marketed by Cephalon (CEPH) in the US.
However, Cephalon terminated its collaboration with Alkermes ever since December 1, 2008. Alkermes entered into an exclusive agreement with Cilag GmbH International, a subsidiary of Johnson & Johnson (JNJ), to commercialize Vivitrol in Russia and other countries in the Commonwealth Independent States (CIS) in 2008. Cilag GmbH International launched the drug in Russia in March 2009.
The sNDA, seeking to expand Vivitrol’s label, is based on positive results from a randomized, multi-center, late-stage study which evaluated the efficacy and safety of Vivitrol for opioid dependence. The study was of six months duration. Alkermes has requested the US agency for a priority review. The approval of this request would imply a six month review timeline.
The study, initiated in June 2008, met its primary as well as all secondary efficacy endpoints. Data from the intent-to-treat (ITT) analysis revealed significantly higher rates of opioid-free urine screens for patients treated with once-monthly Vivitrol compared to those who took placebo.
Vivitrol will be the first and only non-narcotic, non-addictive drug agent to hit the market in a once-monthly formulation in the event of the US agency approving it for the additional indication. We believe that the approval of Vivitrol for the additional indication is essential to boost its sales.
We currently have a Neutral outlook on Alkermes in the long-term implying that it will perform in line with the overall U.S. equity market over the next six to twelve months. We advise investors to retain the stock over the time period.