The Food and Drug Administration has requested that Endo Pharmaceuticals withdraw its Opana ER painkiller from the market. The request shocked lawmakers, advocates and the pharmaceutical industry. This is the first time the agency has made such a move.
The FDA made the request over concerns that the drug is too easily abused. Opana ER is meant to be swallowed and the contents released over 12 hours. However, addicts flocked to Opana because it was easy to crush into a fine powder that could be snorted or injected, allowing them to get the full effect of the drug immediately.
The FDA said data obtained post-marketing showed that more people were finding ways to inject the drug contained in the pill despite a 2012 reformulation designed to prevent that type of abuse. The pill has been blamed for prompting an HIV outbreak in rural Indiana in 2015. The drug has also been linked to reports of a rare but serious blood disease that can lead to organ damage. The agency declined to let the company describe the drug as abuse deterrent in the product labeling.
It is not certain whether Endo will comply with the request. Endo said, “Endo remains confident in the body of evidence established through clinical research demonstrating that Opana ER has a favorable risk-benefit profile when used as intended in appropriate patients.” The drug maker indicated in its statement that it is “reviewing the request and is evaluating the full range of potential options.” Last year, Opana ER generated nearly $159 million in revenue, about 5 percent of the company’s gross revenue.
The FDA could still choose to pursue legal action. If Endo refuses to withdraw the drug, the agency could call a hearing on the proposal to remove it from the market. An administrative law judge could then decide that the drug should be withdrawn and forcibly removed from store shelves.
FDA Commissioner Scott Gottlieb vowed to address the nationwide opioid epidemic before he took the top agency job last month. The agency wouldn’t say if it plans to take action on more opioid products. Spokeswoman Sarah Peddicord said, “The FDA’s work to assess the benefit-risk framework for all opioid medications is part of a broader administration-wide strategy to combat opioid abuse.”