Shares of Endo International plc (ENDP) - Get Endo International Plc Report were down nearly 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.
Endo said in a statement that it is reviewing the FDA's request and is evaluating potential options on the appropriate path forward.
This marks the first time that the FDA is seeking to remove an opioid pain medication from the market due to the public health consequences of abuse, according to the FDA's announcement.
"After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks," the FDA said.
The agency said it based its decision on a review of postmarketing data, which showed a "significant shift in the route of abuse of Opana ER from nasal to injection following the product's reformulation."
"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," said FDA Commissioner Scott Gottlieb, M.D., in the news release.
Malvern, Pa.-based Endo Pharmaceuticals is an operating company of Dublin-based Endo International.
Endo noted that despite the agency's request to withdraw Opana ER, "this request does not indicate uncertainty with the product's safety or efficacy when taken as prescribed." The company added 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."
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