FDA approves Purdue Pharma’s controversial new overdose-reversal medication

Purdue Pharma, the company best known for fueling the opioid crisis by misleadingly marketing the infamous painkiller OxyContin, received approval on Wednesday for a new auto-injector device used to reverse opioid overdoses. 

The announcement represents the latest in a string of recent approvals for products that use nalmefene, essentially a more powerful version of its better-known chemical cousin, naloxone. 

The Food and Drug Administration’s approval of Zurnai, as the device is known, also underscores Purdue’s continued effort to play a role in the nationwide response to the opioid crisis. 

“The FDA remains focused on broadening access to opioid overdose reversal agents, including naloxone and nalmefene,” Robert Califf, the agency’s commissioner, 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 approval is likely to spark anger on multiple fronts. 

Primarily, amid the overdose epidemic, Purdue is viewed as a national villain. Its questionable marketing tactics for OxyContin, in particular, are blamed for turbocharging, beginning in the late 1990s, a wave of opioid addiction. The company and its founders and owners, the Sackler family, have been the subject not only of countless lawsuits but also major books and TV shows. 

Many corners of the addiction advocacy community view Purdue with immense suspicion, and resent the company’s attempts to play a role in addressing a crisis it helped create. In its statement, the company noted that it plans to sell Zurnai at cost, and that it also doesn’t turn a profit on its existing nalmefene drug, which is used in hospital settings. 

“Zurnai can be an important new tool to save lives in critical moments,” Craig Landau, the company’s president, said in a statement. “We are committed to delivering solutions to help address the opioid overdose crisis and are working to provide Zurnai at no profit to the company.” 

Second, the FDA’s approval comes amid a broader debate about the strength of overdose-reversal medications like naloxone and, more recently, nalmefene. 

As fentanyl has overtaken heroin and prescription opioids as the main driver of overdose deaths, overdose responders have reported that victims are slower to respond to standard doses of naloxone. Some first responders and harm reduction groups have responded by incorporating new techniques into their protocol, like rescue breathing. Others have simply administered more doses of cheap, injectable naloxone or even higher-priced nasal spray products like Narcan. 

But the perceived need for larger naloxone doses has also sparked what many public health experts view as a needless pharmaceutical industry arms race. In the past decade, roughly a half-dozen companies rushed to develop high-dose, mechanically complex versions of naloxone that they can sell for hundreds or even thousands of dollars. 

It is unclear whether the high-dose products are more effective. But the way they work — by out-competing opioid molecules in a battle for access to brain receptors — is known to induce severe withdrawal. People recently revived from overdose, in turn, are often likely to leave the care of hospitals or first responders if their symptoms are ignored. More critically, they’re prone to use again in an attempt to stave off those withdrawal symptoms, risking overdose and potentially death. 

Nalmefene, though it works similarly, is far more potent than naloxone. Many harm-reduction groups have expressed skepticism that the medication is more effective at reversing overdoses and warn that the harms of inducing more severe withdrawal could still outweigh any potential benefits. 

The FDA’s decision also comes amid continued controversy surrounding Purdue and the Sackler family, which still owns the Connecticut-based company. 

In June, the Supreme Court struck down a settlement agreement between Purdue and dozens of states and local governments that would have seen the Sacklers pay out as much as $6 billion. 

The agreement would have allowed Purdue to emerge from bankruptcy as a restructured company whose profits would be used for addiction treatment and prevention. But it was mostly notable because it granted the Sacklers immunity from civil lawsuits stemming from the company’s role in the opioid crisis. In a 5-4 decision that transcended the justices’ political ideology, the court ruled that bankruptcy law has no mechanism for granting immunity from civil lawsuits.