For the first time, the FDA has asked a drug company to remove its opioid painkiller off the market.
The FDA requested on Thursday that Endo International take its extended-release opioid painkiller Opana ER (otherwise known as oxymorphone hydrochloride) off the market, after deciding that the drug’s benefits no longer outweighed its risk for abuse.
The FDA rarely asks drugmakers to remove products from the market, and this is the first time it’s asked for an opioid to be removed for a public health reason.
The move could signal a major shift in the way the FDA is confronting the opioid epidemic, potentially leading to more opioids getting requests for removal.
“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 said in a news release.
More than 183,000 people died from overdoses related to prescription opioid painkillers like oxycodone, hydrocodone, fentanyl, and morphine over the last 15+ years.
Endo’s stock was down more than 14% after-hours on Thursday on the news.
When Opana ER is taken properly orally, it slowly releases into the body as intended. But if the drug is snorted or injected, it releases its dose all at once.
In 2012, Endo reformulated Opana to have abuse-deterrent properties. The new formula turned the pill into a gel that supposedly made it hard to snort or inject when crushed. But in 2013, the FDA found Opana was still easy to inject or snort despite the new formulation.
The abuse-deterrent formulation of the drug was likely tied to an HIV outbreak in Indiana in 2015 that resulted in 165 cases of the disease. The CDC interviewed 112 of the people who contracted HIV, finding that 96% of them had injected Opana using shared needles.
By far the most common route of abuse, however, is ingestion, either by taking too many pills at once or crushing it to counter the timed-release properties. No abuse deterrence properties can stop that.
The FDA held an advisory committee hearing in March to discuss whether the drug’s benefits for pain still outweigh its risks. The panel voted that they did not.
In a release, Endo said it was reviewing the FDA’s request and stood up for its drug — when used as intended.
“Endo remains confident in the body of evidence established through clinical research demonstrating that Opana ER has a favourable risk-benefit profile when used as intended in appropriate patients,” the company said.
If Endo doesn’t remove the drug from the market voluntarily, then the FDA can formally withdraw its approval.
The request to the drugmaker came just one month after the Senate confirmed Gottlieb as FDA commissioner, and it could be a signal of what to expect from the agency’s response to the opioid epidemic under his leadership. The FDA is one of many government agencies that play a critical role in public health and drug 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,” Gottlieb said in a release.
That leaves the door open for the FDA to take this kind of action for other prescription painkillers that have been approved but are frequently misused.