The Food and Drug Administration (FDA) asked Endo Pharmaceuticals to take the reformulated version of its powerful opioid painkiller Opana ER off the market claiming the benefits associated with use of the drug no longer outweigh the risks. This is the first time the agency has requested the removal of a currently marketed painkiller due to the risk of abuse.
“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, M.D., said in a news release. “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.”
Opana ER, an extended-release version of Opana IR, was first approved by the FDA in 2006 for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
In 2012, Endo reformulated Opana ER with an abuse-deterrent coating, as required by the FDA for pharmaceutical companies seeking approval for new opioids, in an effort to protect its patent. The coating was to make the drug more difficult to crush and snorted or to be dissolved and injected. However, Endo discovered problems with its abuse-deterrent coating when it came to dissolving the pill.
The decision to remove Opana ER comes after an agency review of all available post-marketing data, which showed a significant shift in how the drug was being abused, from snorting to injecting. The agency also noted the risk for serious blood disorders when injecting dissolved Opana ER, a condition called thrombotic thrombocytopenia purport, which may be caused by the abuse-deterrent coating.
With more information about the risks of the reformulated Opana ER, the FDA is taking steps to remove the reformulated Opana ER from the market.
“The abuse and manipulation of 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, M.D., 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.”
Should Endo choose not to remove Opana ER from the market, the FDA said it would take steps to formally require its removal by withdrawing approval. In the interim, the FDA is asking health care professionals to be aware of the particularly serious risks associated with the abuse of this powerful opioid.
FDA News Release