Opana ER Pulled from Market Following FDA Request

Following a request from the US Food and Drug Administration (FDA), international pharmaceutical company Endo Pharmaceuticals, has pulled its opioid agonist Opana ER (oxymorphone hydrochloride extended release). The request from the FDA stems from concerns that “the benefits of the drug may no longer outweigh its risks,” according to the FDA’s news release.

Opana ER was first approved in 2006 “for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate,” according to Endo’s website.

FDA officials made the withdrawal request based on a review of available postmarketing data, which showed a significant shift in the route of abuse following the product’s reformulation from nasal to injection. According to the FDA’s release, “injection abuse of the reformulated [Opana ER] has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder (thrombotic microangiopathy).”

A report from NPR in March 2016 indicated that although Opana ER was reformulated into pills with a special coating designed to make it harder to crush and then “snort” them, individuals who wanted to "get their fix" figured out a way to remove the protective coating and manipulate the drug to be injected instead. Individuals who were abusing the drug in this manner typically shared needles with other users; it was this practice that triggered major outbreaks of human immunodeficiency virus (HIV) and hepatitis C virus (HCV) in the United States, particularly in Indiana and Tennessee.

During the FDA’s advisory committee meeting in March, a group of independent experts “voted 18-8 that the benefits of reformulated Opana ER no longer outweigh its risks,” according to the FDA release.

Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, stated in the release, “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. This action will protect the public from further potential for misuse and abuse of this product.”

In the company’s press release, Endo announced its plans to work with the 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 health care professionals.”

This request for withdrawal marks “the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequence of abuse,” according to the FDA release. To this end, FDA Commissioner Scott Gottlieb, MD, is quoted in the statement as saying, “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. 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.”