Pfizer’s Troxyca And The Limits Of Advisory Committee Review For Opioids
Executive Summary
FDA approved Pfizer’s oxycodone/naltrexone extended release opioid with abuse deterrent claims similar to Embeda. That isn’t the label FDA’s advisory committee supported.
You may also be interested in...
US FDA Strategy On Abuse-Deterrent Opioids Needs Rethinking, Panelists Say
Deterring intravenous abuse over other routes of abuse should be agency's priority, some advisory committee members say during discussion of abuse patterns and risks with Endo’s reformulated Opana ER.
Keeping Track: Amgen Parsabiv Is Latest To Receive Complete Response; Pfizer Troxyca ER Finally Approved; Remune Returns
The latest drug development news and highlights from our FDA Performance Tracker.
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.