The decision comes less than a month after the U.S. Food and Drug Administration (FDA) requested that drug sales be halted, due to concerns over its potential for misuse and abuse.
On June 8, the FDA announced that an advisory committee had determined that Opana ER tablets—ER stands for extended-relief—had “dangerous unintended consequences” and that “the benefits of the drug may no longer outweigh the risks.” The FDA stated that if Endo did not voluntarily recall the drug, the agency would formally withdrawal approval. (Extended-relief opioids come with increased risks of addiction and overdose.)
At the time, Endo said it was reviewing the request and evaluating its options. Yesterday, the company released a statement saying that while it “continues to believe in the safety, efficacy, and favorable benefit-risk profile of Opana ER,” it has agreed to withdrawal the drug.
“Endo plans to work with FDA to coordinate the orderly removal of OPANA ER in a manner that looks to minimize treatment disruption for patients and allows patients sufficient time to seek guidance from their healthcare professionals,” the company’s statement reads. “Patients taking OPANA ER should discuss treatment options with their prescribing physician at their next visit.”
Opana ER’s reported net sales for the first quarter of 2017 totaled $35.7 million, according to Endo’s statement, and the withdrawal will cost the company approximately $20 million. The statement also notes that “the Company has taken significant steps over the years to combat misuse and abuse,” and reiterates that its decision does not reflect any findings that the drug is not safe or effective when taken as prescribed.
Opioid addiction continues to be a serious problem across the U.S. A report released this week from the Centers for Disease Control and Prevention found that pain-relief prescriptions in the United States vary widely from county to county, with 6 times more opioids-per-resident in regions with the highest prescribing rate compared to the lowest. Counties in northern California, southern Nevada, and parts of Tennessee, Kentucky, and West Virginia had some of the highest per-capita rates.
Content Originally Published By: Amanda MacMilian
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