FDA Rebukes Egalet's Reliance On OxyContin Postmarketing Data
Arymo ER sponsor's consultants said Purdue's postmarketing data on its reformulated oxycodone establish a link between abuse-deterrent properties and reduced real-world abuse, but FDA says it disagreed with the conclusion in the context of an OxyContin labeling supplement.
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Remoxy Review Leaves US FDA Wondering: Where Is The Real-World Data On ADFs?
FDA’s Sharon Hertz opened up an advisory committee review of PTI’s proposed abuse-deterrent formulation of Remoxy by remarking on the absence of data about the real-world impact of approved ADFs. That doesn’t have much to do with Remoxy – which appears headed to yet another rejection – but it is an important message for other sponsors of opioid therapies to heed.
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.
Egalet's Arymo ER Opioid Has Questionable Oral Abuse-Deterrent Effect
Drug liking score in human oral abuse study shows small but statistically significant difference, and clinical relevance is unclear, FDA says in advisory committee briefing documents.