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.
“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, who vowed to address the nationwide problem of opioid addiction and abuse before he took the top agency job last month.
The decision comes three months after an FDA panel voted to yank the drug, which it approved in 2006, but was not considered to be “abuse deterrent.” The pill became notorious after it was blamed for prompting an HIV outbreak in rural Indiana in 2015, and it was also linked to reports of a rare but serious blood disease characterized by clots that can lead to organ damage.
It is unclear, however, whether Endo will comply. 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. We say that because Endo argued that the FDA request “does not indicate uncertainty” that Opana ER is safe or effective when taken as prescribed. “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.”
Of course, the FDA could pursue legal action. Even so, such a clash could have a wide-ranging effect. “A fight from Endo may have upsides,” said Dr. Andrew Kolodny, who heads the Opioid Policy Research Collaborative at Brandeis University. “Endo may argue there are more dangerous opioids that haven’t been pulled- which would be true. 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.
As STAT has noted previously, Opana ER is meant to be swallowed and the contents released over 12 hours, which is known as extended release. 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. For this reason, the withdrawal was praised by one expert.
“This is good news, because it’s exactly what the FDA should be doing,” Dr. Lewis Nelson, who chairs the Department of Emergency Medicine at Rutgers New Jersey Medical School, told us. “If all opioids were required to be abuse deterrent, it would reduce the ability that people have to extract the drug. I think, going forward, that any extended release opioid will have to be abuse deterrent.”
Last year, Opana ER generated nearly $159 million in revenue, although sales have slowed more recently. In this year’s first quarter, the drug notched $35.7 million in sales, down from almost $44.7 million during the same period a year earlier.
This article is reproduced with permission from STAT. It was first published on June 8, 2017. Find the original story here.