Alkermes Starts Opioid-induced Constipation Drug Trial

Alkermes has announced the initiation of a Phase 2b study of ALKS 37, an orally active, peripherally restricted opioid antagonist for the treatment of opioid-induced constipation.

Cambridge, MA-based pharmaceutical company Alkermes has launched its Phase 2b study of ALKS 37, an orally active, peripherally restricted opioid antagonist for the treatment of opioid-induced constipation (OIC).

The multicentre randomised double-blind placebo-controlled fixed-dose study will evaluate the safety and efficacy of daily administration of a 100mg dose of ALKS 37 versus placebo for 12 weeks in approximately 80 patients with OIC.

In the study, the primary efficacy endpoint is the change from baseline in the frequency of weekly complete spontaneous bowel movements (CSBMs) during the initial four weeks of the treatment period. Additional endpoints of the study include the change from baseline in the frequency of weekly spo