Shares of Endo International plc (ENDP) were down almost 13% to $11.99 in after-hours trading on Thursday, June 8, following word that the U.S. Food and Drug Administration had requested that Endo Pharmaceuticals Inc. pull its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market.
It's the first time the FDA has asked to pull an opioid pain drug from the market based on the public health consequences of its use. But the Philadelphia area pharmaceutical company said in a statement that it's reviewing the FDA's request "and is evaluating the full range of potential options" before it decides on the best path to take forward.
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. 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.
Wall Street responded quickly with a sell-off, and Endo shares plunged 13.4 percent to $11.93 in trading after US markets closed.
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Donnelly said, "This is welcome news, and I am pleased by the FDA's action".
In March, an advisory committee of independent experts voted 18 to eight that the benefits of the drug no longer outweighed its risks.
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. 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.
About 2 million Americans are addicted to prescription opioids, and 91 die every day from overdosing on a painkiller or much-cheaper heroin. The FDA intends to continue issuing warnings and informing the public about the risks of Opana use in the meantime. 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. "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".
Opana ER brought in $158 million in sales a year ago for Endo, a 10 percent drop from 2015 because of generic competition, according to FiercePharma, a trade site.