FDA Approves Zurnai Auto-Injector for Opioid Overdose

The FDA has approved Purdue Pharma's ZurnaiTM (nalmefene injectable) Auto-Injector. Zurnai is a single-dose auto-injector designed to treat opioid overdoses in adults and paediatric patients 12 years of age and above. It provides 1.5 mg of nalmefene hydrochloride each actuation. It is not intended to replace emergency medical attention, nor should it be administered to those who are known to be allergic to any of the product's constituents, including nalmefene hydrochloride.

According to preliminary data, 90% of opioid overdose deaths for the 12 months ending in February 2024 were caused by synthetic opioids, mostly fentanyl. In order to combat high-potency synthetic opioids, the National Institutes of Health encourages the development of stronger, longer-acting opioid antagonist formulations. Zurnai offers an alternative choice for treating opioid overdoses, including those resulting from prescription drugs and synthetic opioids produced illegally. The auto-injector is straightforward to use and includes nalmefene, the longest-acting opioid antagonist licensed for opioid overdose reversal.

Currently, Purdue supplies hospital emergency rooms across the nation with single-dose vials of nalmefene hydrochloride injection that contain 2 mg/2 mL (1 mg/mL) for use by medical personnel.