Opioid Abuse-Deterrence: Immediate Release Formulation Is Chance For US FDA To Reassess Goal Posts
Inspirion's RoxyBond would be first immediate-release oxycodone with abuse deterrent properties, and it seems backed by solid data, but first it needs to make it past two advisory committee all too familiar with the law of unintended consequences.
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RoxyBond Clears US FDA With Abuse-Deterrent Properties, But No REMS Yet
Inspirion's oxycodone is first immediate-release opioid approved with abuse-deterrent language in labeling.
Abuse-Deterrent Opioids: Postmarketing Data Eyed As Development ‘Anchor’
Panelists at US FDA advisory committee on Inspirion's RoxyBond note reservations about abuse-deterrent claims absent more real-world data on how they work; FDA's Staffa suggests agency is eager to see how well premarket work predicts postmarket experience – though the data are far from being available.
RoxyBond Gets US Advisory Panel OK For Abuse-Deterrent Claim Despite Excipient Concerns
Members unanimously endorse product and mostly supported abuse-deterrent language; several panelists suggest warning about possible harmful effects of excipients by abusing product intravenously.