The FDA has asked Endo Pharmaceuticals to remove opioid painkiller Opana ER from the market, saying that in the midst of an opioid addiction crisis, its risks outweigh its benefits.
In 2012, Endo replaced the original formulation of Opana ER with a new formulation meant to make the drug resistant to physical and chemical manipulation for abuse by snorting or injecting, but the FDA determined that the data did not show that the reformulation could be expected to meaningfully reduce abuse and declined the company's request to include labeling describing potentially abuse-deterrent properties for Opana ER. If Endo doesn't remove the drug from the market voluntarily, then the FDA can formally withdraw its approval.
The move marks the first time the agency has called for the removal of an opioid painkiller for public health reasons and comes after a panel of advisers concluded in March that the drug's benefits did not outweigh the risks. "When we determined that the product had unsafe unintended consequences, we made a decision to request its withdrawal from the market", Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research said in the FDA's prepared statement.
Opana ER was approved by the FDA for pain management in 2006 as an extended-release opioid. Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder (thrombotic microangiopathy).
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.
"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", says Dr. Scott Gottlieb, the FDA's commissioner, in announcing the move. It also marks the first time that the US regulator that has sought to remove an opioid painkiller from the market over public safety concerns, Reuters noted.
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Endo first got USA approval for its extended-release opioid, Opana ER, in 2006.
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.
The FDA said Thursday that subsequent data showed a "significant shift" in the route of abuse "from nasal to injection" after the reformulation.
Opioids were involved in more than 33,000 deaths in 2015 and opioid overdoses have quadrupled since 1999, according to the Centers for Disease Control and Prevention. Some other states and cities have filed similar lawsuits.
"When we determined that the product had unsafe and unintended consequences, we made a decision to request its withdrawal from the market", Woodcock said.
Those generic products might also face action by the FDA, which said it is "assessing the latest available data on abuse patterns".