The U.S. Food and Drug Administration, or FDA, Thursday requested Endo Pharmaceuticals remove its opioid pain medication Opana ER from the market due to risks.
Opana ER, manufactured by Endo, was first approved by the FDA in 2006 for the management of moderate-to-severe pain.
It follows a March 2017 FDA advisory committee meeting where independent experts voted 18-8 that the benefits of reformulated Opana ER no longer outweigh the risks.
“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.
“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. Scott Gottlieb, said in a press release.
as declared in As word of the FDA request circulated, shares of Endo International dipped almost 13% to $11.99 on Thursday.
The company also said that when taken as prescribed, the drug “has a favorable risk-benefit profile.”The FDA first approved Opana ER in 2006.
The FDA is asking Ireland-based Endo Pharmaceuticals to stop selling reformulated Opana ER, or oxymor phone hydro chloride, because the risks outweigh any benefits of pain control, the FDA said in a statement Thursday.
The FDA, however, found that “data did not show that the reformulation could be expected to meaningfully reduce abuse.”
In 2012, Endo released a newly formulated version intended to make the drug resistant to abuse by snorting or injecting.
as declared in
Risk of abuse: FDA wants opioid painkiller pulled from market
as declared in The agency says this the first time it has asked that an opioid pain medication be pulled due to “the public health consequences of abuse.”
The US Food and Drug Administration said Thursday that drugmaker Endo Pharmaceuticals must remove its powerful opioid painkiller Opana ER from the market.
“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. Scott Gottlieb said.
Endo 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.”
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.
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