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Data on Vivitrol for opioid dependence showed sustained efficacy over 18 months
Date:11/9/2011

DUBLIN, Ireland, Nov. 9, 2011 Alkermes plc (NASDAQ: ALKS) today presented positive results from a long-term study of VIVITROL (naltrexone for extended-release injectable suspension) at the 24th Annual U.S. Psychiatric and Mental Health Congress in Las Vegas, NV. Results from the one-year, open-label extension of the six-month pivotal study showed sustained efficacy of VIVITROL, as measured by the number of opioid-free urine screens, in patients who received VIVITROL, in combination with psychosocial treatment, for a total of 18 months of treatment. Additionally, all safety events observed during the open-label extension were consistent with those set forth in the approved product labeling.

"The robust data from this extension study confirm VIVITROL's efficacy and safety profile over an 18-month period and support its clinical utility as a treatment option for opioid dependence, following opioid detoxification," stated Evgeny Krupitsky, M.D., Ph.D., Professor of Psychiatry, St. Petersburg State Pavlov Medical University and Head of the Department of Addictions at the Bekhterev Research Psychoneurological Institute. "VIVITROL is the first and only once-monthly medication that offers patients and physicians a non-narcotic treatment option to help fight this challenging disease."

During the total observation period of 18 months, improvements during the six-month pivotal trial observed in patients treated with VIVITROL were maintained for the duration of the subsequent one-year, open-label extension study. Half of the patients (49%) who entered the one-year extension study, after receiving six months of VIVITROL in the pivotal study, were completely abstinent for the duration of the extension study, based on opioid-free urine screens. The response profile based on the number of opioid-free urine screens was the primary efficacy endpoint of the six-month pivotal study. The extension study also measured opioid craving, improvements in quality o
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Contact: Jennifer Snyder
781-609-6166
Alkermes plc
Source:Eurekalert

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