Remoxy Review Leaves US FDA Wondering: Where Is The Real-World Data On ADFs?

 
• By Michael McCaughan
  
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FDA’s Sharon Hertz opened up an advisory committee review of PTI’s proposed abuse-deterrent formulation of Remoxy by remarking on the absence of data about the real-world impact of approved ADFs. That doesn’t have much to do with Remoxy – which appears headed to yet another rejection – but it is an important message for other sponsors of opioid therapies to heed.

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“At this point in time, it is reasonable to conclude that the utility of abuse-deterrent analgesics has yet to be determined in the real world.” • Source: SOURCE: Shutterstock

FDA had a list of four questions for its expert advisory committee to address during its review of Pain Therapeutics Inc.'s extended-release oxycodone formulation Remoxy, related to the product's proposed abuse-deterrent properties and overall approvability. But Division of Anesthetic, Analgesia and Addiction Products Director Sharon Hertz opened up the meeting by raising a very different question: where is the postmarketing data showing that approved abuse-deterrent formulations (ADFs) are having the intended impact of deterring abuse?

There are now 10 products approved with formal abuse-deterrence claims by FDA, with the most widely used (Purdue Pharma...

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