Drug for Opioid-induced Constipation Headed for Phase 1 Clinical Trial

An orally active, peripherally-restricted opioid antagonist designed to aid in the treatment of opioid-induced constipation, will be initiated into a multidose phase 1 clinical study by Alkermes, Inc.

ALKS 37 has the potential to block the effects of opioid agonists on gastrointestinal motility. The randomized, double-blind, placebo-controlled study will assess the the safety, tolerablitiy, and pharmacokinetics of daily oral administration of two dose levels over seven days. There will be approximately 24 volunteers.

Alkermes representatives said they believe the drug may have the potential to reverse severe side effects of opioid administration with low systemic exposure and little to no central nervous system penetration.