Alkermes plc (ALKS) Announces Results from Phase 2 Study of ALKS 37 for Treatment of Opioid-Induced Constipation
5/31/2012 9:42:10 AM
DUBLIN--(BUSINESS WIRE)--Alkermes plc (NASDAQ: ALKS) today 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 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 our 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.