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

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 the agency should not consider abuse-deterrent claims for a particular...