As Purdue Pharma attempts to restore its image following its role in the U.S. opioid crisis, the Connecticut-based company has scored a win with a green light for a new overdose rescue treatment.
This week, the FDA approved Purdue’s nalmefene injection Zurnai to treat known or suspected opioid overdoses in adults and kids ages 12 and older. The drug, which comes in a 1.5 mg autoinjector, can be used to treat overdoses from both prescription opioids and synthetic opioids such as fentanyl, Purdue said in a release.
Zurnai is meant for immediate use in emergency settings and is not a substitute for medical care, the company added.
The medicine’s autoinjector has been designed for ease of use by “anyone in the community,” from healthcare professionals and first responders to bystanders, caregivers and family members, Purdue said.
The active ingredient in Zurnai, nalmefene, is the longest-acting opioid antagonist approved for overdose reversal, according to Purdue’s release. Prior to Zurnai’s approval, Purdue had already been supplying nalmefene hydrochloride injection to emergency departments across the U.S. at no profit.
Purdue’s nalmefene autoinjector nod comes a little more than a year after Indivior’s Opvee became the first approved nalmefene nasal spray. Indivior got its hands on the opioid overdose reversal agent through its $145 million buyout of Opiant in late 2022. Like Zurnai, Opvee is approved for use in people ages 12 and up.
Zurnai was approved based on safety and pharmacokinetic studies, plus a study in healthy people who use opioids recreationally, to see how quickly the product works, the FDA said in its own press release.
And while Zurnai certainly may have a role to play in preventing deaths from overdoses, the FDA warned of the unexpected consequences of using the med on people who are opioid dependent—an issue that has raised concerns about overdose reversal agents writ large.
If patients who are opioid dependent are given Zurnai, they may go into opioid withdrawal. In turn, people addicted to opioids who recover from an overdose may leave the care of doctors or first responders if their symptoms are ignored, and they’re at risk of using opioids again in an effort to curb withdrawal symptoms, STAT News reports.
Drug overdoses continue to pose a major health threat in the U.S., and more than 107,000 fatal overdoses were reported last year, the FDA said. Those deaths were primarily driven by synthetic opioids like illicit fentanyl, the agency warned.
The approval comes less than two months after the Supreme Court blocked a multi-billion-dollar bankruptcy agreement for Purdue Pharma and its founding family, the Sacklers.
Under the proposed deal, the Sacklers were set to return up to $6 billion to Purdue’s bankruptcy estate in exchange for immunity from civil lawsuits tied to the nationwide opioid crisis.
Over the years, Purdue Pharma and the Sacklers have faced countless lawsuits and a swarm of public criticism for the role that their misleading OxyContin marketing played in the U.S. opioid crisis.
Back in 2020, Purdue Pharma agreed to plead guilty in federal court to a three-count felony charge tied to a “dual-object conspiracy to defraud the United States and to violate the Food, Drug, and Cosmetics Act.” The company also pleaded guilty to two counts of conspiracy to violate the Federal Anti-Kickback Statute.
As part of the decision, Purdue was slapped with a $3.5 billion criminal fine, plus an additional $2 billion criminal forfeiture—a punishment the U.S. Justice Department at the time called the “largest penalty ever levied against a pharmaceutical manufacturer.”
Perhaps most notably, under the resolution, Purdue was forced to cease to operate in its original form and emerge from bankruptcy as a public benefit company (PBC) to “function entirely in the public interest,” the Justice Department said.