FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Requests Endo Remove Opioid Painkiller Opana ER from the Market After Reports of Abuse

June 14, 2017
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The FDA requested that Endo Pharmaceuticals voluntarily remove its opioid painkiller Opana ER from the market, saying its benefits may no longer outweigh its risks of abuse — the first time the agency has taken steps to remove a currently marketed opioid from sale.

Postmarket data showed changes in the main route of abuse of Opana ER (oxymorphone hydrochloride), from snorting to intravenous injection, after the pill was reformulated to make it difficult to crush into a fine powder or have it turn into a thick gel when mixed with water. While gelling made IV abuse more difficult, diluting the drug with extra water led abusers to rely on more frequent injections.

“We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse,” FDA Commissioner Scott Gottlieb said.

The FDA’s decision follows a March advisory committee meeting, where members voted 18-8 to recommend that the drug’s risks outweighed its benefits. Opana ER was first approved in 2006 for long-term, around-the-clock pain management.

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