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FDA takes aim at opioid epidemic

Agency wants to pull opioid from market because it says the drug’s benefits don’t outweigh its risks

by Lauren K. Wolf
June 16, 2017 | A version of this story appeared in Volume 95, Issue 25

The U.S. Food & Drug Administration has requested that Endo Pharmaceuticals remove its painkiller Opana ER from the market. Opana ER’s active ingredient, oxymorphone, is an opioid similar to morphine but with an added hydroxyl group that makes it 10 times as potent.

The agency says this is the first time it has taken steps to halt sales of an opioid over concerns of public abuse. In 2012, Endo reformulated Opana ER to make it harder for people to crush the drug, and thereby snort it, and to dissolve the drug, and thereby inject it. The firm did so with help from German drugmaker Grünenthal’s Intac technology, which uses a high-molecular-weight polyethylene oxide and proprietary excipients to make it difficult to break the pills into fine particles and to make them gel when dissolved.

Still, people with opioid addiction have figured out ways to inject it, and FDA says illicit use of Opana ER has been associated with an outbreak of HIV and hepatitis C. “We are facing an opioid epidemic—a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” said newly appointed FDA Commissioner Scott Gottlieb in a statement. Endo says it’s currently evaluating its “full range” of options.


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