Recently, Alkermes Inc. (ALKS) announced that its drug Vivitrol, which is indicated for the treatment of alcohol dependence, also helped opioid addicts stay away from drugs. Data from the six-month late-stage trial (n=250) demonstrated that subjects injected with Vivitrol (naltrexone for extended-release injectable suspension) once a month were more likely to pass a urine test compared to recipients of a placebo injection. Furthermore, subjects reported a lower craving for drugs, and half the subjects came clean in at least 90% of their drug tests.
 
The subjects were addicted to opioid drugs including heroin. Before enrolling for the trial, they had to stay away from drugs for at least a week. The most common adverse event affecting patients during the study were inflammation of the nose and throat in addition to insomnia.
 
The positive results have formed the basis of Alkermes’ decision to file a supplemental new drug application (sNDA) for the indication with the U.S. Food and Drug Administration (FDA) in the first half of calendar 2010.
 
As a reminder, Naltrexone is marketed in the U.S. as Vivitrol since winning the U.S.   approval in 2006. It is marketed as a once-monthly intramuscular injection for the treatment of alcohol dependence. The phase III trial of Vivitrol for the treatment of opioid dependence was initiated on Jun 26, 2008.
 
 
Mid-stage study commences for ALKS 33
 
Alkermes announced that it has initiated phase II studies for its pipeline candidate ALKS 33. The candidate is being developed for treating alcohol dependence in addition to other central nervous system disorders.
 
The mid-stage multi-center, double-blind, placebo-controlled 12-week study (n~440) is designed to assess the safety and efficacy of multiple doses of ALKS 33 in patients with alcohol dependence, which will help to further define the profile of the candidate.
 
We remind investors that a key action date for Alkermes is coming up in 2010 when the FDA decides on the company’s type II diabetes candidate, exenatide once-weekly. Exenatide once weekly is an injectable formulation of Amylin Pharmaceuticals’ (AMLN) Byetta (exenatide). We believe that approval may get delayed due to safety concerns surrounding glucagon-like peptide-1 (GLP-1) molecules such as exenatide.
 
Currently, we are Neutral on Alkermes.

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