FDA Panel to Review ALKS Drug - Analyst Blog

Recently, Alkermes, Inc. (ALKS) announced that its supplemental New Drug Application (sNDA) for Vivitrol (naltrexone for extended-release injectable suspension) for the opioid dependence indication will be reviewed by the US Food and Drug Administration’s (FDA) Psychopharmacologic Drugs advisory committee tentatively on Sep 16, 2010. A response from the FDA is expected to be out in the third quarter of fiscal 2011 (target date: Oct 12, 2010). 

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 for the treatment of alcohol dependence. The drug received FDA approval in 2006. 

The 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. 

The study 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. 

At the time of submitting the application, Alkermes had requested priority review. The request was approved by the FDA in May 2010. The US regulatory authority generally reviews those drugs on a priority basis which offer major advances in treating diseases having no adequate therapy. Applications for priority review designated drugs are reviewed by the FDA within six months of submission as against the usual ten months.

We believe that the approval of Vivitrol, already available for the treatment of alcohol dependence, for the additional indication is essential to boost its sales. 

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 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.
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