FDA Requests Withdrawal Of Endo's Opana ER
The US regulatory agency has decided the long-acting opioid's benefits no long outweigh its risks, sparking concern that other strong steps on opioid abuse could be coming.
You may also be interested in...
Concerns that the extended-release oxycodone product poses the same potential for intravenous abuse as Endo’s withdrawn Opana ER drive FDA advisory committee recommendation against approval, laying the groundwork for a fourth complete response letter; FDA’s comparison of Remoxy to Opana during the meeting ‘borders on slanderous,’ PTI CEO Barbier tells Scrip, predicting sponsors will be dissuaded by the shifting regulatory goalposts for abuse-deterrent formulations.
‘Dramatic action’ needed to curb opioid epidemic, commissioner-nominee says, including potentially a cross-center approach to evaluating drugs and devices for pain, and new nomenclature for formulations currently labeled as abuse deterrent.
Given concerns about completing Phase III trials, advisory committee member asks whether US FDA has considered ‘the possibility of an expanded access protocol,’ but agency official points to added complexity that comes with the pathway; bioethics experts talk to the Pink Sheet about pros and cons of expanded access vs. EUA pathways.