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Alkermes (ALKS) Decides Not To Advance Opioid-Induced Constipation Treating Study

 May 30, 2012 06:12 PM

(By Balaseshan) Alkermes Plc (NASDAQ:ALKS), an integrated biotechnology company, said it has decided not to advance ALKS 37 study to treat opioid-induced constipation after the results of phase 2b dose-ranging clinical study.

The company announced topline results from a phase 2b dose-ranging clinical study of ALKS 37 in the treatment of opioid-induced constipation. The multicenter, randomized, double-blind, placebo-controlled, repeat-dose study was designed to assess the safety, tolerability, pharmacokinetic profile and efficacy of ALKS 37 in about 150 patients.

ALKS 37 was generally well tolerated at all dose levels, and while subjects taking ALKS 37 demonstrated an increase in bowel movements compared to baseline, the product profile did not satisfy our pre-specified criteria for advancing into phase 3 clinical trials.

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Based on this evaluation, Alkermes has decided not to advance ALKS 37 and will consider out-licensing opportunities. A second phase 2b study of ALKS 37 for the treatment of opioid-induced constipation is concluding, and no additional clinical studies for ALKS 37 are planned.

Based on the results of this study, the company said it would focus its future clinical development efforts on other development programs, including ALKS 9070 for schizophrenia and ALKS 5461 for major depressive disorder.

Chief Medical Officer Elliot Ehrich said the company would continue to maintain a disciplined approach to research and development and focus its resources on clinical candidates that show the most promise.

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ALKS closed Wednesday's regular session down 3.14% at $16.06. The stock has been trading between $13.48 and $20 for the past 52 weeks.

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