Purdue Pharma announced that the FDA approved its new drug application (NDA) for the Zurnai (nalmefene injection) auto-injector.

The single-dose auto-injector delivers 1.5 mg of nalmefene hydrochloride per actuation. It marks the approved first nalmefene hydrochloride auto-injector for the emergency treatment of known or suspected opioid overdose. The agency approved the first nasal spray formulation of nalmefene in May 2023.

These approvals all followed the approval of Narcan as a prescription drug in 2015. Narcan is now available over-the-counter in nasal spray form as well.

Approval covers the emergency treatment of known or suspected opioid overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older, as manifested by respiratory and/or central nervous system depression. Its uses cover immediate administration as emergency therapy in settings where opioids may be present. It is not a substitute for emergency medical care.

Purdue said Zurnai provides an additional option to address overdoses caused by opioids. This includes both prescription opioids and illicitly manufactured, synthetic opioids. Purdue’s autoinjector contains nalmefene, the longest-acting opioid antagonist approved for opioid overdose reversal. The company said it designed the device for ease-of-use.

Anyone in the community, including healthcare professionals, first responders, caregivers, family members and bystanders can administer.

“We are pleased to gain approval of Zurnai, the nalmefene auto-injector for use by healthcare professionals or anyone in the community,” said Dr. Craig Landau, president and CEO, Purdue. “Zurnai can be an important new tool to save lives in critical moments. 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.”