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ALKS Gains FDA Approval

publication date: Oct 12, 2010

From ALKS Press Release:

Alkermes, Inc. (NASDAQ: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved VIVITROL® (naltrexone for extended-release injectable suspension) for the prevention of relapse to opioiddependence, following opioid detoxification. VIVITROL is now the first and only non-narcotic, non-addictive, once-monthly medication approved for the treatment of opioid dependence. VIVITROL was approved by the FDA in 2006 for the treatment of alcohol dependence and should be used as part of a comprehensive management program that includes psychosocial support.

“Opioid dependence is a serious and chronic illness characterized by high rates of relapse,” stated Dr. Marc Fishman, Assistant Professor of Psychiatry, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine. “VIVITROL is an opioid-blocking medication that offers patients and physicians a once-monthly medication to prevent relapse to opioid addiction.”

“As an organization that helps families find treatment and offers support for loved ones with addiction, we see firsthand that opioid dependence is one of the most significanthealth issues facing our nation. This new indication for Alkermes’ product as a non-addictive approach to prevent relapse to opioid dependence brings new hope to the families we serve,” said Steve Pasierb, President and Chief Executive of The Partnership at Drugfree.org.

“Opioid dependence is a growing disease and we believe that VIVITROL offers physicians and their patients a whole new approach, as the only long-acting, non-addictive treatment for opioid dependence,” stated Richard Pops, Chief Executive Officer of Alkermes. “We look forward to helping to improve the lives of patients with this chronic and debilitating condition.”

The FDA approval of VIVITROL for the prevention of relapse to opioid dependence was based on data from a six-month, multi-center, randomized phase 3 study which met its primary efficacy endpoint and all secondary efficacy endpoints. Data from the intent-to-treat analysis showed that patients treated once a month with VIVITROL demonstrated statistically significant higher rates of opioid-free urine screens compared to patients treated with placebo (p<0.0002). VIVITROL was generally well tolerated in the study. The most common clinical adverse events experienced by patients receiving VIVITROL during the study were hepatic enzyme elevations, nasopharyngitis and insomnia.