Naloxegol CV Safety Findings “Reassuring” – NEJM Study
This article was originally published in The Pink Sheet Daily
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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FDA appreciated Purdue’s “Herculean” attempt to demonstrate the cardiovascular safety of its abuse-deterrent Targiniq ER, but the agency emphasized that studies must include more chronically-treated patients and should not exclude patients with a history of cardiovascular disease.
Opioid-induced constipation drugs are best handled by the alternative approaches to cardiovascular safety data collection favored by public/private group of experts, sponsors argue.
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.