In a bid to thwart the opioid epidemic, the Food and Drug Administration has asked Endo Pharmaceuticals to withdraw its Opana ER painkiller over concerns that the drug is too easily abused, the first time the agency has made such a move.
In a statement, the drug maker indicated it is “reviewing the request and is evaluating the full range of potential options.” In fact, the company appears ready for a fight.
It could lead to other formulations being pulled.” In explaining its move, though, the FDA said post-marketing data indicated more people were finding ways to inject the drug contained in the pill, despite a 2012 reformulation that was designed to prevent such abuse.
The agency, in fact, determined the reformulation was not expected to “meaningfully reduce abuse” and declined to let the company describe the drug as abuse deterrent in the product labeling.
But addicts have been attracted to Opana because it was easy to crush into a fine powder that could be snorted or injected to get the full effect of the drug immediately.