Endo Pharmaceuticals has agreed to remove its abuse-deterrent extended-release formulation of oxymorphone (Opana ER) from the US market, about a month after the US Food and Drug Administration (FDA) asked the company to stop selling the pain medication.
In a statement, the company said it "continues to believe in the safety, efficacy, and favorable benefit-risk profile" of Opana ER when used as intended. "Nevertheless, after careful consideration and consultation with the FDA following the FDA's June 2017 withdrawal request, the company has decided to voluntarily remove Opana ER from the market."
As previously reported by Medscape Medical News, the FDA asked Endo Pharmaceuticals to take Opana ER off the market on the basis of a review of postmarketing data, which demonstrated a significant shift in the route of abuse of Opana ER from nasal administration to injection after the product's reformulation.
Injection abuse of reformulated Opana ER has been associated with an outbreak of HIV infection and hepatitis C virus infection, as well as cases of thrombotic microangiopathy, the FDA said.
"The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak. When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market," Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said in a news release in June. "This action will protect the public from further potential for misuse and abuse of this product."
This is the first time the FDA has taken steps to remove a currently marketed opioid pain medication from sale because of the public health consequences of abuse.
The request by the FDA came on the heels of a March meeting of an FDA advisory panel of independent experts who voted 18 to 8 that the benefits of reformulated Opana ER for relief of severe pain no longer outweigh its risks.
Endo Pharmaceuticals said it will work with the FDA to coordinate the "orderly removal" of Opana ER to minimize treatment disruption for patients and allow patients sufficient time to seek guidance from their healthcare provider on other treatment options.
According to the company, net sales of Opana ER were $158.9 million in 2016 and $35.7 million in the first quarter of 2017.
Cite this: Endo Pharma Agrees to Pull Abuse-Deterrent Opioid - Medscape - Jul 06, 2017.