The Food and Drug Administration asked Endo Pharmaceuticals on Thursday to remove its extended-release opioid painkiller Opana ER from the market. Endo shares, which were up 11 percent at the close of the stock market, fell more than 12 percent in after-hours trading.
“After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks,” the FDA said in a statement. “This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse.”
The decision came after an FDA advisory panel voted 18-8 in March that the benefits of Opana ER no longer outweigh the risks. Post-marketing data showed a significant shift in the route of abuse from nasal to injection, the FDA said. The drug, first approved in 2006 to manage pain from moderate to severe enough to require daily, around-the-clock, long-term opioid treatment, was reformulated in 2012 with the intent to resist physical and chemical manipulation by snorting or injecting.
Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder known as thrombotic microangiopathy, the agency said.
“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,” FDA Commissioner Scott Gottlieb said in a statement.
Endo, which has its U.S. headquarters in Malvern, said it was reviewing the request and “evaluating the full range of potential options.” The company said when taken as prescribed, Opana ER has a favorable risk-benefit profile. Despite the advisory committee vote in March, Endo said that more than half the panel members “expressed their preference that Opana ER remain on the market, but with additional regulatory restrictions to mitigate the risks of misuse and abuse.”
The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak. “When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “This action will protect the public from further potential for misuse and abuse of this product.”