The U.S. Food and Drug Administration asked Endo International PLC to remove its opioid pain medication, reformulated Opana ER, from the market.
In its request, the regulator said it seeks removal of the drug based on its concern that the benefits of the drug may no longer outweigh its risks, marking the first time the FDA has asked to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse.
Endo responded to the FDA's request stating that it was reviewing the request and evaluating all options as it determines the appropriate path forward. It also said that the regulator's request did not indicate uncertainty with the product's safety or efficacy when taken as prescribed.
In addition, the company said it remains confident of the evidence established through clinical research that demonstrates that Opana ER has a favorable risk-benefit profile when used as intended in appropriate patients.
The FDA said its decision was based on a review of all available post-marketing data, that showed a significant shift in the route of abuse of the drug from nasal to injection after the product's reformulation. Injection abuse of reformulated Opana ER has been linked to a serious outbreak of HIV, hepatitis C and cases of thrombotic microangiopathy, a blood disorder.
Previously, the FDA's advisory committee voted that the benefits of Opana ER no longer outweighed its risks.
"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 FDA Commissioner Scott Gottlieb. "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," he added.
The director of the FDA's Center for Drug Evaluation and Research, Janet Woodcock, said the abuse and manipulation of reformulated Opana ER by injection had resulted in a serious disease outbreak and the FDA decided to request the withdrawal when it determined that the product had dangerous unintended consequences.
In case Endo does not comply with the withdrawal request, the FDA will take steps to formally require its removal by withdrawing approval.
Opana ER was first approved in 2006 for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended time period. In 2012, Endo replaced the original formulation with a new formulation intended to make the drug resistant to physical and chemical manipulation for abuse by snorting or injecting.
The product met regulatory standards for approval, but the regulator determined that the data did not show that the reformulation could be expected to meaningfully reduce abuse and declined the company's request to include labeling describing the drug's potentially abuse-deterrent properties.