Naloxegol CV Safety Findings “Reassuring”

Naloxegol CV Safety Findings “Reassuring” – NEJM Study

06 Jun 2014

AstraZeneca’s peripherally acting mu-opioid receptor antagonist was not associated with an increased incidence of major cardiovascular events in Phase III studies of chronic pain patients with opioid-induced constipation. An FDA advisory committee will review CV safety data for the drug class June 11-12.

Two pivotal trials of AstraZeneca PLC/Nektar Therapeutics’s investigational opioid receptor agonist naloxegol revealed no cardiovascular safety concerns, investigators said in a New England Journal of Medicine article published just days ahead of an FDA advisory committee meeting on CV risks for the drug class.

“Major cardiovascular events were rare, and their occurrence was balanced across the groups in both studies,” William Chey, University of...