'Wow.' In A First, FDA Requests An Op...
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Jun
13
Sandeep Singh Dhillon
‘Wow.’ In A First, FDA Requests An Opioid Be Pulled From The Market – Forbes
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By Matthew Herper

In a dramatic first, the Food and Drug Administration is requesting that a manufacturer, Endo Pharmaceuticals, remove an opioid drug, Opana ER, from the market because of its potential for causing 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,” said FDA Commissioner Scott Gottlieb in a prepared statement. “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.”

“Wow,” said Andrew Kolodny, the director of the Opioid Policy Research Collaborative at Brandeis University. “This is the first time I’ve seen FDA pull an opioid off the market.The question is will they stop here? Because there are some opioids where at least the upper doses should come off the market.”

Opioid overdoses killed 33,000 Americans in 2015, with half of those involving a prescription opioid. Overuse and abuse of the drugs have become a national crisis, and have also helped spur the use of illicit drugs like heroin.

Opana ER was approved in 2006 for patients who need round-the-clock pain relief. In 2012, Endo reformulated the drug to make it more resistant to physical and chemical tampering that makes it easier to abuse, for instance, by crushing and snorting. While the drug met the standards for approval, FDA says Endo never showed that the reformulation would reduce abuse, and Opana was never allowed to claim that it would in marketing materials.

Instead, the new formulation seemed to lead to a spike in intravenous use of Opana. Users would inject the new formulation, instead of crushing and snorting it. This change in behavior led to an HIV outbreak in Indiana. In a statement, Janet Woodcock, the head of the FDA’s Center for Drug Evaluation and Research, specifically attributed the decision to recommend Opana’s removal with that outbreak.

In March, an FDA advisory panel recommended that Opana should come off the market. But Kolodny, for one, was skeptical that it would happen. The FDA generally follows the recommendations, but not always. In 2013, the agency approved a new opioid, Zohydro, despite the fact that an advisory committee panel had recommended 11-2 that Zohydro should stay off the market.

Kolodny vocally opposed the selection of Gottlieb as FDA commissioner because of his ties to drug companies. But Kolodny now says he’s encouraged by this decision. “Maybe, like they say, only Nixon could go to China,” Kolodny says. “Maybe he will make the changes that have been needed for a long time.” The first other drug on Kolodny’s list? Subsys, the Binaca-like fentanyl spray made by Insys Therapeutics. It’s supposed to be used for cancer patients, but there is evidence it was marketed to people who did not have cancer. “That spray is like a lethal weapon,” Kolodny says.

Oxycontin was removed from the market when an abuse-resistant form became available, but that was done at the behest of manufacturer Purdue Pharma, not at the FDA’s request.

If a manufacturer chooses not to honor the FDA’s request to removing a product from the market, the agency can take legal action to force it to do so.

Last year, Opana ER generated sales of $159 million, down significantly from its peak of about $300 million. Endo has annual sales of $4 billion. In a statement, Endo said it is “evaluating the full range of potential options” and emphasized its “strong sense of responsibility” to patients. Shares in Endo traded down 13.6% to $11.90 in after-hours trading.



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