Regulatory Affairs

FDA asks Endo to withdraw opioid painkiller over abuse risks

PBR Staff Writer Published 12 June 2017

The US Food and Drug Administration (FDA) has asked Endo Pharmaceuticals to withdraw its Opana ER (oxymorphone hydrochloride) from the market owing to increased abuse of the reformulated opioid pain medication.

The removal was sought after concerns that the risks associated with consuming the drug outweighed its benefits, stated the FDA.

In fact, it marks the first time that the regulator has taken initiative to ban a currently marketed opioid pain medication from sale because of consequences of abuse to public health.

FDA Commissioner Scott Gottlieb said: “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.”

Endo said that it was reviewing the FDA request and is assessing a full range of possible options before taking the next step.

Endo stated: “Despite the FDA's request to withdraw Opana ER from the market, this request does not indicate uncertainty with the product's safety or efficacy when taken as prescribed.

“Endo remains confident in the body of evidence established through clinical research demonstrating that Opana ER has a favorable risk-benefit profile when used as intended in appropriate patients.”

According to the FDA, its decision to seek a withdrawal of Opana ER was made on the grounds of a post-marketing data in which there was a clear case of a considerable shift in the route of abuse of the opioid pain drug from nasal to injection post the reformulation of the product.

The regulator said that injection abuse of the reformulated drug has been linked to serious HIV and hepatitis C outbreaks, and also posing risks to cause a serious blood disorder.

First approved by the FDA for the management of moderate-to-severe pain in 2006, Opana ER was reformulated six years later to make it resistant to physical and chemical manipulation for abuse by injecting or snorting.