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Opana Safety Review Will Set Tone For Opioid Regulation Under Trump

Executive Summary

FDA’s 2017 advisory committee calendar is extremely light, but the one product focused review on the schedule should be a doozy: a two-day look at safety issues with Endo’s Opana ER as well as generic versions of oxymorphone. The topic is likely to resonate with the Trump Administration and especially Vice President Pence.

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The Politics Of Opana: US FDA’s Opioid Problems Won’t Go Away

A two-day safety review of Endo’s reformulated Opana ER provided strong support for FDA’s view that products using abuse-deterrent technology cannot simply be assumed to be 'safer' than conventional formulations. However, there are also no easy answers for when and how FDA will be able to move out of the hot seat on opioid abuse.

Opana ER: Effort To Expand US Label Might Lead To Withdrawal Due To Abuse Problems

FDA advisory committees will weigh concerns that Endo’s reformulated version of oxymorphone extended-release, which does not contain abuse-deterrent labeling, has shifted preferred non-oral route of abuse from intranasal to intravenous, which carries additional safety risks.

Endo’s Opana ER, Generic Oxymorphone Safety Get US FDA Panel Review

Advisory committee to discuss data on abuse of Opana ER and generic oxymorphone extended-release and immediate-release products.

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