FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Advisory Committees Say Opana ER Benefits No Longer Outweigh Risks

March 21, 2017
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Two FDA advisory committees voted that the benefits of a previously approved formulation of Opana ER no longer outweigh the risks of abuse.

The March 13-14 joint meeting reviewed safety concerns surrounding the potent opioid painkiller sponsored by Endo Pharmaceuticals, which is approved for 24-hour control of pain. Committee members were asked to consider three observational studies examining whether changes in the drug’s formula to deter abuse had unintended effects.

The FDA’s Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products advisory committees weighed data from three real-world, epidemiological studies examining abuse of Opana ER before and after its reformulation with polyethylene oxide, or PEO — which is included in several extended-release opioids approved by the FDA.