FDA Calls On Drugmaker To Pull A Powerful Opioid Off The Market


US regulators want a narcotic painkiller involved in the opioid epidemic off the market amid data showing people continue to abuse it.

The U.S. Food and Drug Administration said on Thursday it has asked Endo International Plc to withdraw from the market its long-lasting opioid painkiller Opana ER, sending the company's shares down more than 12 percent.

It's the first time the FDA has asked a drugmaker to remove an opioid painkiller from the market.

The company must now choose between voluntarily taking Opana off the market or face an impending formal FDA drug approval withdrawal. Injections of the drug by people with an addiction disorder have continued to trigger outbreaks of HIV, which causes the acquired immune deficiency disorder (AIDS), and hepatitis C, potentially fatal liver infection, as well some cases of the serious blood disorder known as thrombotic microangiopathy.

Though it is a "good sign" for the fight against opioid abuse, he said, "Opana is not the only one that needs to come off the market".

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An FDA advisory committee voted in March that Opana ER's benefits no longer outweighed its risks.

Gottlieb said the agency 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 sold $158 million worth of Opana ER in 2015, had reformulated the pills in 2012 and sought to get them labeled as abuse deterrent.

It is the first time the agency has taken steps to remove an opioid pain medication due to the public health implications of abuse.

In a written statement, Endo says the company is "reviewing the request and is evaluating the full range of potential options as we determine the appropriate path forward".

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. Opana ER, oxymorphone hydrochloride, is used to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternatives aren't strong enough, according to the manufacturer's website.

Opana ER was approved by the FDA for pain management in 2006 as an extended-release opioid.

Those generic products might also face action by the FDA, which said it is "assessing the latest available data on abuse patterns".

"Despite the FDA's request to withdraw Opana ER from the market, this request does not indicate uncertainty with the product's safety or efficacy when taken as prescribed". The company, which is based in Dublin and has its USA headquarters in Malvern, Pa., recently announced two rounds of job cuts.