FDA Asks Drug Company to Pull Its Opioid Opana Because of Abuse
FDA Asks Drug Company to Pull Its Opioid Opana Because of Abuse
Andrew Brookes | Getty Images
09 June, 2017, 09:34
"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.
Although a reformulated version of Opana ER had been approved in 2013 to discourage its abuse, people abusing the drug simply changed from inhaling it to injecting it, which led to serious outbreaks of HIV and Hepatitis C, the statement said. The move follows an FDA advisory committee vote of 18-8 in March concluding the drug's risks were greater than the benefits. Opana ER is one of a group of drugs that makes up Endo's pain category which had sales of $486 million for the 12 months of 2016.
In explaining its move, though, the FDA said post-marketing data indicated more people were finding ways to inject the drug contained in the pill, despite a 2012 reformulation that was created to prevent such abuse.
In a statement, the company said it was reviewing the FDA's request but that it "remains confident in the body of evidence established through clinical research demonstrating that Opana ER has a favorable risk-benefit profile when used as intended in appropriate patients".
The FDA said Thursday that subsequent data showed a "significant shift" in the route of abuse "from nasal to injection" after the reformulation.
"When we determined that the product had unsafe 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.
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It is the first time the agency has taken steps to remove an opioid pain medication due to the public health implications of abuse.
This is the first time that the federal agency has requested that a drug company voluntarily stop selling a medication because of the risk of abuse that the drug carries, the FDA said in a statement. The company defended its drug, a version of the medicine oxymorphone hydrochloride, citing the opioid's effectiveness in alleviating pain and Endo's efforts to prevent abuse. "When we determined that the product had risky unintended consequences, we made a decision to request its withdrawal from the market".
The FDA says it has approved 10 opioid medications as abuse-deterrent, including Pfizer Inc.'s Troxyca and Purdue Pharma LP's OxyContin. 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.
Those generic products might also face action by the FDA, which said it is "assessing the latest available data on abuse patterns". In the meantime, the FDA is making healthcare professionals aware of the risks associated with the powerful painkiller.
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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