In a first for the U.S. Food and Drug Administration, the regulator has requested Endo Pharmaceuticals to remove its reformulated Opana ER (oxymorphone hydrochloride) opioid drug from the market. The move follows an FDA advisory committee vote of 18-8 in March concluding the drug’s risks were greater than the benefits.
The milestone echoes Gottlieb’s acknowledging of the need to take steps to stem the opioid crisis in his confirmation hearing testimony earlier this year. It also marks the first time that the U.S. regulator that has sought to remove an opioid painkiller from the market over public safety concerns, Reuters noted.
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“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 Gottlieb in a news 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.”
The FDA indicated that if Endo declines to remove Opana ER voluntarily, the agency would withdraw approval for the opioid.
In April at his Senate confirmation hearings Gottlieb described the opioid epidemic as the biggest crisis facing the FDA.
“The opioid epidemic in this country is having staggering human consequences,” Gottlieb said in response to a questions from the Senate Health, Education, Labor and Pensions Committee. He also singled out opioid alternatives as one of the greatest opportunities to turn the tide on the crisis.
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Although a reformulated version of Opana ER had been approved in 2013 to discourage its abuse, people abusing the drug simply changed from inhaling it to injecting it, which led to serious outbreaks of HIV and Hepatitis C, the statement said.
In response to the news, Endo’s share price plummeted. But the Philadelphia area pharmaceutical company said in a statement that it’s reviewing the FDA’s request “and is evaluating the full range of potential options” before it decides on the best path to take forward. Opana ER is one of a group of drugs that makes up Endo’s pain category which had sales of $486 million for the 12 months of 2016. The category saw a 24 percent decline in sales year over year due to intensifying competition from generic producers.
Matthew Herper at Forbes noted that Oxycontin was removed from the market when an abuse-resistant form became available, but the difference was that Purdue Pharma initiated that — the action wasn’t at the FDA’s request.
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