Remoxy's Woes Stoke Criticism Of FDA's Review Of Abuse-Deterrent Opioids
FDA's complete response letter includes extensive list of new studies needed to support abuse-deterrence claims not featured in two prior CRLs, Pain Therapeutics says, wondering why the agency is only now raising issues that could have been discussed previously.
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Agency reviewers see lower potential for intranasal abuse with Pain Therapeutics' extended-release opioid compared to immediate-release oxycodone, but an increased abuse potential when Remoxy is chewed compared to swallowing the drug intact.
Citizen petition resembles July 2016 petition targeting extended-release oxycodone products, but this time names the products it's worries about.
Keeping Track: Vitaros Reenters The Wilderness, Remoxy Gives It A Fourth Try, And Two Novel Approvals
The latest drug development news and highlights from our US FDA Performance Tracker.