Endo Pharmaceuticals announced that it is voluntarily recalling Opana ER after "after careful consideration and consultation with the FDA" following their removal request. While the company says that it still believes in the safety and efficacy of the product when used correctly, the company has agreed to comply with the FDA's request made in early June.
According to a press release, Endo said that it will work with the FDA to make the removal from market safe and to create limited disruption to patients.
Opana sales reached over $158 million in 2016 and nearly $36 million in the first quarter of 2017.
Original story follows:
For the first time, the FDA is requesting that an opioid be removed from the market because of its potential for abuse.
Endo Pharmaceuticals must remove its reformulated Opana ER (oxymorphone hydrochloride) from the market. “This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse,” the FDA said in a statement.
“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 in the announcement. “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 agency’s decision is based on a review of all available post-marketing data, which demonstrated “a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation,” FDA said.
Injection abuse of reformulated Opana ER has been associated with a “serious outbreak” of HIV and hepatitis C, as well as cases of the blood disorder thrombotic microangiopathy, according to FDA.
“When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market,” said Janet Woodcock, MD, 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.”
A group of independent experts voted that the benefits of reformulated Opana ER no longer outweigh its risks, at a March FDA advisory committee meeting.
Opana ER was first approved in 2006 for the management of moderate-to-severe pain for patients needing a continuous around-the-clock opioid analgesic for an extended period of time.
Then, 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,” FDA said. “Now, with more information about the risks of the reformulated product, the agency is taking steps to remove the reformulated Opana ER from the market.”
FDA says it will continue to examine the risk-benefit profile of all approved opioid analgesic drugs “and take further actions as appropriate, as a part of our response to this public health crisis.”