(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
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
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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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.