Opioids Need Post-Marketing Data To Inform Abuse-Deterrent Claims, FDA Panel Says

Pfizer’s extended-release opioid Troxyca ER receives advisory committee recommendation for approval and two of three abuse-deterrent labeling claims, but members also want post-marketing data to help make future decisions.

Pfizer Inc.’s extended-release opioid Troxyca ER (oxycodone/naltrexone) received positive advisory committee recommendations June 8, but they came with a call for FDA to make decisions about abuse-deterrent claims that are informed by post-marketing data.

One member of the joint Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees even suggested...

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