FDA Pulls Opioid From Market; More Actions Possible

On June 8, the FDA issued an announcement that asked Endo Pharmaceuticals to remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market.

They said that it was removing the drug because the benefits of the drug may no longer outweigh its risks. This is the first time the FDA has taken a previously approved opioid pain medication from sale due to the public health consequences 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,” said FDA Commissioner Scott Gottlieb, M.D. “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.”

The FDA’s decision was based on a review of all available postmarketing data, which demonstrated a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation.

Injection abuse of reformulated Opana ER, said the FDA, was found to be associated with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder (thrombotic microangiopathy).

This decision follows a March 2017 FDA advisory committee meeting where a group of independent experts voted 18-8 that the benefits of reformulated Opana ER no longer outweigh its risks.

Opana ER was first approved in 2006 for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

In 2012, Endo replaced the original formulation of Opana ER with a new formulation intended to make the drug resistant to physical and chemical manipulation for abuse by snorting or injecting. While the product met the regulatory standards for approval, the FDA determined that the data did not show that the reformulation could be expected to meaningfully reduce abuse and declined the company’s request to include labeling describing potentially abuse-deterrent properties for Opana ER.

Now, with more information about the risks of the reformulated product, the agency took the extraordinary step of reversing itself and asking Endo to remove Opana ER from the market.

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

If Endo fails to remove the product, the FDA will take steps to formally require its removal by withdrawing approval.

Clearly, this action by the FDA sends a powerful message to all over suppliers of approved opioid analgesic products. The FDA made the point in its public announcement regarding Opana ER that it is continuing to review the opioid public health crisis and may take further actions.