Purdue Pharma on Wednesday won FDA approval for its emergency treatment for opioid overdose as the company attempts to distance itself from its role in the opioid epidemic.
The nalmefene hydrochloride auto-injector, known as Zurnai, is approved for adults and children who are at least 12 years old. Nalmefene is a longer-acting opioid reversal agent than naloxone, which has been used to treat overdoses for decades.
Zurnai will be the first nalmefene auto-injector in the US, though Indivior has a nasal spray formulation called Opvee. It’s administered in a single-dose, prefilled auto-injector and is only available by prescription.
“The FDA remains focused on broadening access to opioid overdose reversal agents, including naloxone and nalmefene,” FDA Commissioner Robert Califf said in a statement. “Today’s approval adds a new nalmefene product and route of administration to support greater options for opioid overdose reversal.”
The Supreme Court recently rejected Purdue’s attempt to settle opioid-related lawsuits through bankruptcy. The plan would have shielded the Sackler family, which owned Purdue, from a “broad sweep of present and future” opioid claims.
The court denied the plan in a 5-to-4 ruling, with the majority determining that “nothing in present law authorizes the Sackler discharge.”
In a statement, Purdue said the decision “does nothing to deter us from the twin goals of using settlement dollars for opioid abatement and turning the company into an engine for good.”
The FDA said there were more than 107,000 reported fatal overdoses in 2023, primarily from synthetic opioids.
Purdue stressed in a news release that Zurnai is not a substitute for emergency medical care, noting that the drug is not recommended for “patients known to be hypersensitive to nalmefene hydrochloride or to any other ingredients in the product.”