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.
You may also be interested in...
Opana ER Looking At REMS – Or Worse – After US FDA Panel Weighs Intravenous Abuse Risk
Most advisory committee members say Endo’s reformulated long-acting opioid no longer has a favorable risk/benefit profile due to increased intravenous abuse; panelists split on whether drug should be taken off market or if restrictive REMS would suffice.
Opana Safety Review Will Set Tone For Opioid Regulation Under Trump
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.
FDA's Opioid Policy Reboot: New Risk-Benefit Model, Real-World Data
Science Board also suggests ways to improve REMS-mandated prescriber education.