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Mixed Messaging: Tier 2 Abuse-Deterrent Opioid Claim Illusive

 
• By Sarah Karlin-Smith

FDA’s description of Purdue’s Targiniq abuse-deterrent mechanism seems to match up with a Tier 2 claim that the company didn’t receive, but the agency says this isn’t confusing.

FDA’s labeling and its own public remarks about the abuse-deterrent mechanisms behind Purdue Pharma LP’s newly approved opioid Targiniq paint conflicting pictures about the drug’s abuse-deterrent properties and raise questions about how a company can secure the Tier 2 abuse-deterrent labeling claim and how much those tiers really matter.

The agency said Targiniq (oxycodone/naloxone) doesn’t have a Tier 2 claim, which indicates the abuse-deterrent properties of an opioid are...

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