FDA approval for Zurnai Auto-Injector: A new weapon in the fight against opioid overdose

In a major development in the battle against the opioid epidemic, Purdue Pharma’s Zurnai Auto-Injector has been granted approval by the US Food and Drug Administration (FDA) for the emergency treatment of opioid overdose. This approval marks a significant step forward in public health efforts to combat the rising tide of opioid-related deaths across the United States.

The Zurnai Auto-Injector is a single-dose device designed to deliver 1.5 mg of nalmefene hydrochloride—a potent opioid receptor antagonist—either subcutaneously or intramuscularly. This approval follows the FDA’s May 2023 nod for a nasal spray formulation of nalmefene, underscoring the agency’s commitment to expanding the available options for opioid overdose reversal.

The Zurnai Auto-Injector is now authorized for use in both adults and pediatric patients aged 12 and older. It is particularly vital in cases of respiratory and central nervous system depression induced by opioid overdose, where rapid intervention is critical. The device is intended for use by prescription only, ensuring that it is deployed effectively in emergency situations.

FDA Commissioner Robert Califf highlighted the importance of this approval, stating that the new nalmefene product and its route of administration add to the arsenal of tools available to reverse opioid overdoses. Califf also emphasized that the FDA’s Overdose Prevention Framework, launched in 2022, is a key part of the agency’s strategy to address the ongoing overdose crisis, which continues to devastate communities across the nation.

The approval of the Zurnai Auto-Injector was supported by rigorous safety and pharmacokinetic studies. These included a study involving healthy individuals who use opioids recreationally, which aimed to evaluate the time it takes for the product to take effect. The FDA’s decision was informed by data showing that nearly 90% of opioid overdose deaths in the 12 months ending in February were linked to synthetic opioids like fentanyl.

Purdue Pharma, the company behind the Zurnai Auto-Injector, is no stranger to the opioid crisis. The company has been at the center of numerous lawsuits related to its role in marketing OxyContin, a prescription opioid painkiller that has been widely blamed for fueling the epidemic. However, with the Zurnai Auto-Injector, Purdue Pharma President and CEO Craig Landau expressed the company’s commitment to providing solutions that save lives in critical moments, noting that the product will be offered at no profit to the company.

This approval comes amid ongoing efforts to hold companies accountable for their roles in the opioid epidemic. In February, French advertising firm Publicis Health and Hikma Pharmaceuticals reached separate settlements totaling $500 million in connection to allegations that they contributed to the crisis. Publicis was accused of helping Purdue Pharma develop marketing strategies that boosted OxyContin sales, while Hikma was alleged to have failed in monitoring and reporting suspicious opioid orders.

The Impact of FDA’s Overdose Prevention Efforts

The FDA’s Overdose Prevention Framework has been a cornerstone in the fight against the opioid epidemic. Since its launch, the agency has focused on increasing access to overdose reversal agents like naloxone and nalmefene, aiming to reduce the staggering number of overdose deaths. The framework is part of a broader strategy that includes harm reduction, better treatment options, and improved data collection to monitor the crisis.

The Zurnai Auto-Injector’s approval is expected to play a crucial role in emergency response efforts, particularly in community settings where quick access to opioid overdose treatment can mean the difference between life and death.

The Critical Need for Multiple Overdose Reversal Options

Experts in public health and addiction medicine have lauded the FDA’s decision to approve the Zurnai Auto-Injector. The availability of different formulations of nalmefene, including both the nasal spray and auto-injector, offers flexibility in emergency situations. Having multiple options available ensures that responders can choose the most appropriate method of administration based on the circumstances. Furthermore, the quick action of the Zurnai Auto-Injector could significantly improve outcomes for overdose victims.