For the first time, the U.S. Food and Drug Administration is asking that a pharmaceutical company withdraw a currently marketed opioid pain medication because of the drug’s potential for abuse.
The FDA is asking Ireland-based Endo Pharmaceuticals to stop selling reformulated Opana ER, or oxymorphone hydrochloride, because the risks outweigh any benefits of pain control, the FDA said in a statement Thursday. Endo has global headquarters in Dublin but a U.S. base in Malvern, Pa.
The request comes as the United States finds itself in the middle of what the federal Department of Health and Human Services describes as an “unprecedented opioid epidemic.” More people died in 2014, the most recent year for which data is available, from drug overdoses than any other year on record and more than 60% of those deaths involved an opioid, the federal government says.
As word of the FDA request circulated, shares of Endo International dipped almost 13% to $11.99 on Thursday.
The FDA said in its statement that if Endo does not meet its request, it will take steps to withdraw approval of the drug, prescribed when someone needs a long-term pain medication. Endo reformulated Opana ER in a way that the company said would curb the potential for abuse, but an FDA advisory committee voted 18-8 (with one abstention) in mid-March that the benefits of the reformulated version no longer outweigh risks of the drug.
“The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “This action will protect the public from further potential for misuse and abuse of this product.”
FDA Commissioner Scott Gottlieb said in a statement: “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.”
Endo said in a statement released Thursday that it is evaluating the FDA request, but also pointed out that during the mid-March meeting, more than half of the advisory committee members said they preferred that Opana ER stay on the market but with added restrictions to prevent abuse.
“Endo is reviewing the request and is evaluating the full range of potential options as we determine the appropriate path forward,” the company said.
The company also said that when taken as prescribed, the drug “has a favorable risk-benefit profile.”
The FDA first approved Opana ER in 2006. In 2012, Endo released a newly formulated version intended to make the drug resistant to abuse by snorting or injecting. The FDA, however, found that “data did not show that the reformulation could be expected to meaningfully reduce abuse."