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

 
• By Bridget Silverman

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.

With safety concerns emerging about the cardiovascular safety of opioid receptor antagonists, Purdue Pharma LP embarked on an extensive and complex attempt to satisfy FDA’s concerns about its opioid agonist/antagonist combo Targiniq ER (extended-release oxycodone/naloxone) before approval – an effort FDA lauded even as the agency still insisted on a post-marketing observational study.

The Targiniq review shows that FDA is unlikely to be swayed by pre-marketing analyses of CV events from existing efficacy...

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