Date: 2012-05-30
Type of information: Results
phase: 2b
Announcement: results
Company: Alkermes (USA - Ireland)
Product: ALKS 37
Action mechanism:
Disease: opioid-induced constipation
Therapeutic area: Digestive diseases
Country:
Trial details:
Latest
news: Alkermes has 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. 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.
