4:01PM Alkermes announces ALKS 37 product profile did not satisfy their pre-specified criteria for advancing into phase 3 clinical trials (ALKS) 16.06 -0.52 : Co announces 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 approximately 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 pre-specified criteria for advancing into phase 3 clinical trials. Based on this evaluation, Alkermes has decided not to advance ALKS 37 and will consider out-licensing opportunities. "We had predetermined the product profile we needed to observe in order to continue to advance ALKS 37 into phase 3 clinical studies. Based on the results of this study, we will focus our future clinical development efforts on our other development programs, including ALKS 9070 for schizophrenia and ALKS 5461 for major depressive disorder, we will continue to maintain a disciplined approach to R&D and focus our resources on clinical candidates that show the most promise." 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.
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