FDA Requests Reformulated Oxymorphone Product Removed for Abuse Risk

FDA Asks Drug Company to Pull Painkiller in First

The Food and Drug Administration asked Endo Pharmaceuticals Thursday to remove its extended-release opioid painkiller Opana ER from the market.

The FDA says it has seen a "significant shift" from people crushing and snorting Opana ER to get high to injecting it. The FDA "is looking broadly at the whole policy framework" used for the painkillers, he said in an interview Thursday.

"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 said.

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Endo is reviewing the FDA's request and evaluating all its options "as we determine the appropriate path forward", it said in a statement.

Opana ER (oxymorphone hydrochloride) was first approved by the FDA in 2006 for use by people with moderate or severe chronic pain. The move follows an FDA advisory committee vote of 18-8 in March concluding the drug's risks were greater than the benefits. There have also been cases of a serious blood disorder called thrombotic microangiogpathy linked to the abuse of the drug. If the company does not choose to do so voluntary, the FDA will force the issue by withdrawing its approval for the drug. Opana ER was reformulated in 2012 to make it harder to crush, ideally reducing abuse through snorting the painkiller.

"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", FDA Commissioner Dr. It also marks the first time that the USA regulator that has sought to remove an opioid painkiller from the market over public safety concerns, Reuters noted.

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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.

"When we determined that the product had risky unintended consequences, we made a decision to request its withdrawal from the market", said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research in a statement. Some other states and cities have filed similar lawsuits.

"The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak", said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. "When we determined that the product had risky unintended consequences, we made a decision to request its withdrawal from the market". "This action will protect the public from further potential for misuse and abuse of this product".

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Randall Stanicky, an analyst at RBC Capital Markets, said Opana ER is a declining asset whose sales are expected to fall to US$97 million in 2019, down from an estimated US$134 million in 2017.

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