FDA Crushes Endo’s Hopes, Allows Original Opana Generics To Remain On Market
This article was originally published in The Pink Sheet Daily
Executive Summary
The agency finds reformulated Opana insufficient to deter abuse through most routes of administration and decides the original version was not removed from the market for efficacy and safety reasons; Endo had weaker in vitro and post-market data than Purdue did in its successful Oxycontin petition.
You may also be interested in...
Opana ER Should Come Off The US Market, FDA Tells Endo
Agency seeks long-acting opioid’s withdrawal due to evidence the reformulated version increased intravenous abuse; FDA’s action, which Endo is weighing, portends a hard-line stance when it comes to opioid risks under new Commissioner Scott Gottlieb.
US FDA Strategy On Abuse-Deterrent Opioids Needs Rethinking, Panelists Say
Deterring intravenous abuse over other routes of abuse should be agency's priority, some advisory committee members say during discussion of abuse patterns and risks with Endo’s reformulated Opana ER.
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.