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

10 Mar 2017

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.

Two US FDA advisory committees will consider whether Endo Pharmaceuticals Inc.’s reformulated Opana ER (oxymorphone extended-release) should be withdrawn from the market, or face other regulatory action, due to safety concerns.

In briefing documents released March 9, FDA says epidemiological data suggest the reformulated product, which was introduced in 2013, has...