By Amy Wallace | June 9, 2017 at 10:54 AM
The pain medication reformulated Opana ER, or oxymorphone hydrochloride, is the first opioid drug the agency has requested be taken off the market.
This is the first time the FDA has requested the removal of a currently marketed opioid pain medication from sale due to risks to public health based on abuse. It follows a March 2017 FDA advisory committee meeting where independent experts voted 18-8 that the benefits of reformulated Opana ER no longer outweigh the risks.
“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 Dr. Scott Gottlieb, said in a press release. “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.”
In 2012, Endo replaced the original formulation of Opana ER with a new formulation to make the drug resistant to physical and chemical manipulation for abuse by snorting or injection.
The FDA determined that although it met regulatory standards for approval, the data did not show the reformulation could be expected to meaningfully reduce abuse and declined Endo’s request to include labeling describing potentially abuse-deterrent properties for Opana ER.
The decision to remove Opana ER from sale was based on a review of all available post marketing data, which revealed a significant shift in the route of abuse of the drug from nasal to injection following its reformulation.
Injection abuse of reformulated Opana ER has been linked to a serious outbreak of HIV, hepatitis C and thrombotic microangiopathy, a serious blood disorder.
For its part, Endo stated in a press release Thursday that it is reviewing the FDA’s request and evaluating the full range of potential options to determine the appropriate path forward.
“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,” the company said. “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.”