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Targiniq Review Shows How High FDA’s CV Safety Bar Is For Opioid Antagonists

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

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.

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