Even as it defended the product’s safety when appropriately used, Endo International withdrew from the market its long-acting opioid agonist Opana ER, in compliance with a June 8 Food and Drug Administration request. The company “continues to believe in the safety, efficacy, and favorable benefit-risk profile of Opana ER (oxymorphone hydrochloride extended release) when used as intended, and notes that the company has taken significant steps over the years to combat misuse and abuse,” according to a news release posted on Endo’s website. “Nevertheless, after careful consideration and consultation with the FDA following [its] June 2017 withdrawal request, the company has decided to voluntarily remove Opana ER from the market.”
In fact, the data showed a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation. Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a thrombotic microangiopathy.
Endo said it will work with FDA to coordinate a smooth removal of the product, and insisted that the drug is safe and effective.
“Endo reiterates that neither the FDA’s withdrawal request nor Endo’s decision to voluntarily remove Opana ER from the market reflect a finding that the product is not safe or effective when taken as prescribed. To the contrary, Endo remains confident in the clinical research and other data demonstrating Opana ER’s safety and efficacy, as well as its favorable risk-benefit profile when used as intended in appropriate patients.”
Opana ER was first approved in 2006 for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. It was reformulated in 2012, with the intent of making it “resistant to physical and chemical manipulation for abuse by snorting or injecting,” according to the FDA release.
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