Endo Pulls Opioid From US Market at FDA's Request

Regulatory NewsRegulatory News | 06 July 2017 |  By 

Endo International announced Thursday that it will comply with the US Food and Drug Administration’s (FDA) request to remove its opioid Opana ER (oxymorphone hydrochloride extended release) from the US market.

FDA made the request 9 June “based on its concern that the benefits of the drug may no longer outweigh its risks” after "a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation.”

As a result, the Dublin-based company said it expects to incur a pre-tax impairment charge of approximately $20 million in the second quarter of 2017. Net sales of Opana ER in 2016 were $158.9 million.

FDA Viewpoint

FDA Commissioner Scott Gottlieb and CDER Director Janet Woodcock on Thursday wrote in a JAMA viewpoint that the agency “can do more to confront” the opioid crisis.

While describing the agency’s look into the illicit use of Opana ER, Gottlieb and Woodcock note that the agency has commissioned a study from the National Academies of Sciences, Engineering, and

Medicine to identify additional actions the agency should consider to address the opioid crisis, “with a particular focus on approaches the agency can take to improve its benefit-risk framework for opioids to support a more formal assessment of the public health risks and benefits.”

FDA has also recently pledged to take a closer look at the data supporting abuse-deterrent labeling for opioids.

Petition to Remove Other Opioids

The decision to pull Opana ER from the US market also comes as the Center for Lawful Access and Abuse Deterrence on 3 July petitioned FDA to require companies that do not have abuse-deterrent opioids to convert products to such formulations within three years or have their products removed from the market.

“Our current petition provides manufacturers of non-abuse-deterrent opioids with three years from the date of this Citizen petition or the date of a third ADO approval, to remove their product and replace it with an ADO, leaving adequate time for transition,” the petition says.


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