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Naloxegol CV Safety Findings “Reassuring” – NEJM Study

This article was originally published in The Pink Sheet Daily

Executive Summary

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.

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Naloxegol development program included long-term controlled trial, the advisory committee’s preferred approach for studying CV events with peripherally active mu opioid receptor antagonists for opioid-induced constipation, while methylnaltrexone may suffer from the lack of control arm in its long-term study.

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