The decision came one month after the first-ever FDA recommendation for a drug withdrawal on the grounds of opioid abuse.
Endo International has voluntarily pulled OPANA ER (oxymorphone hydrochloride extended release) from the market, just a month after the US Food and Drug Administration (FDA) submitted a withdrawal request for the injection pain treatment.
Since first being approved in 2006, the opioid pain medication was reformulated from a nasal to injection treatment. Postmarketing data showed a significant shift in opioid abuse following the reformulation, leading to the FDA's recommendation to withdraw it in June. It was the first time the administration had made an effort to remove a marketed opioid due to concerns of abuse.
“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,” FDA Commissioner Scott Gottlieb, MD, said at the time. “We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse.”
OPANA ER was associated with a serious outbreak of human immunodeficiency virus (HIV) and hepatitis C, as well as cases of a serious blood disorder (thrombotic microangiopathy), at the time of withdrawal consideration.
The drug had accrued $158.9 million in full-year net sales in 2016, and another $35.7 million for the first quarter of 2017, according to Endo International. Moving forward, the pharmaceutical company will be coordinate an "orderly removal" of OPANA ER with the aid of the FDA — in a manner that would minimize current patient treatment disruption.
In a press release regarding the decision, Endo International reiterated neither their withdrawal nor the FDA recommendation reflected any finding of the product's efficacy or safety.
"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," the press release statement read.
A press release regarding the removal was made available.