Endo International Plc has agreed to the FDA’s request that it remove the opioid pain reliever Opana ER from the market because of problems with abuse. An FDA advisory panel had ruled that the risks of the long-acting opioid painkiller outweigh the drug’s benefits.

The FDA approved Opana ER in 2006. Because the drug was being abused, a reformulated version was put on the market in 2012. The FDA advisory panel noted that the rate of abuse for the nasal spray form of the drug did indeed fall, but rates of intravenous abuse soared.

The withdrawal comes amid a nationwide opioid abuse epidemic that the FDA has vowed to combat, Reuters reports. The agency’s commissioner, Scott Gottlieb, has made the epidemic a top priority, stating that the agency will continue to “take regulatory steps” in situations where the risks appear to outweigh the benefits.

Endo defended the drug, saying in a statement that it “continues to believe in the safety, efficacy, and favorable benefit–risk profile of Opana ER (oxymorphone hydrochloride extended release) when used as intended, and … that the company has taken significant steps over the years to combat misuse and abuse.

“Nevertheless, after careful consideration and consultation with the FDA following the FDA's June 2017 withdrawal request, the company has decided to voluntarily remove Opana ER from the market,” Endo said. It expects to incur a pre-tax impairment charge of about $20 million in the second quarter of 2017 to write off the remaining net book value of the drug, which had reported net sales of $158.9 million in 2016.

Endo plans to work with the FDA to coordinate the orderly removal of Opana ER in a manner that minimizes treatment disruption.

Sources: Reuters; July 6, 2017; Endo; July 6, 2017.


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