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Opana ER Looking At REMS – Or Worse – After US FDA Panel Weighs Intravenous Abuse Risk

 
• By Sue Sutter

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.

Endo Pharmaceuticals Inc.’s reformulated Opana ER (oxymorphone extended-release) should either be removed from the market, or its prescribing limited through new labeling and a strict Risk Evaluation Mitigation Strategy (REMS), due to concerns about increased intravenous abuse of the long-acting opioid, US FDA advisory committee members said March 14.

Eighteen of 27 members of the Drug Safety and Risk Management and the Anesthetic and Analgesic Drug Products advisory committees voted that the benefits

Advisory Committee Vote

Do the benefits of reformulated Opana ER continue to outweigh its risks

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