FDA asks drugmaker to stop selling its opioid painkiller

Ellen Mills
June 9, 2017

As the United States battles a growing opioid abuse crisis, the Food and Drug Administration on Thursday asked Endo International Plc to withdraw from the market its long-lasting opioid painkiller, Opana ER, sending Endo's shares down more than 12 percent.

This marks the first time the FDA has taken steps to remove a now marketed opioid pain medication from sale due to the public health consequences of opioid abuse. The FDA says if Endo doesn't voluntarily pull the drug from the market, it will withdraw approval. "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".

Endo, which has its USA headquarters in Malvern, said it was reviewing the request and "evaluating the full range of potential options".

This is one of the first policy decisions by the agency since Scott Gottlieb was appointed FDA commissioner by President Trump, who had talked about the opioid crisis during his campaign.

An FDA advisory committee voted in March that Opana ER's benefits no longer outweighed its risks. The pill became notorious after it was blamed for prompting an HIV outbreak in rural in 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.

Endo had tried to make it harder for addicts to use Opana ER by making it with a coating that made it hard to crush.

From 2000 to 2015, almost 180,000 Americans died from overdoses of prescription opioids, and tens of thousands more have succumbed to heroin and fentanyl overdoses as the crisis has evolved.

Endo first got US approval for its extended-release opioid, Opana ER, in 2006.

The agency has been criticized in the past for examining the safety and effectiveness of individual opioid painkillers without considering the wider impact each could have on the nation's epidemic.

The FDA didn't agree, refusing to let Endo market the new formulation as abuse deterrent when it granted approval for sales several years ago. Some other states and cities have filed similar lawsuits.

"When we determined that the product had unsafe unintended consequences, we made a decision to request its withdrawal from the market", Woodcock added in a statement.

Those generic products might also face action by the FDA, which said it is "assessing the latest available data on abuse patterns". Although the reformulated drug was approved, the FDA later determined that this change did not "meaningfully reduce abuse".

Opana ER brought in $158 million in sales previous year for Endo, a 10 percent drop from 2015 because of generic competition, according to FiercePharma, a trade site.

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