FDA approves Zurnai (nalmefene injection) Auto-Injector for the emergency treatment of known or suspected opioid overdose induced by natural or synthetic opioids in adults and pediatric patients 12 years and older

Zurnai (zur nye) is a single-dose auto-injector that delivers 1.5 mg of nalmefene hydrochloride per actuation.

Zurnai is indicated for 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. Zurnai is intended for immediate administration as emergency therapy in settings where opioids may be present. Zurnai is not a substitute for emergency medical care. Zurnai is contraindicated in patients known to be hypersensitive to nalmefene hydrochloride or to any other ingredients in the product.

“We are pleased to gain approval of Zurnai, the nalmefene auto-injector for use by healthcare providers or anyone in the community,” said Craig Landau, MD, 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.”

Provisional data for the 12-months ending February 2024 show that approximately 90% of opioid overdose deaths were from synthetic opioids (primarily fentanyl). Furthermore, opioid overdose deaths among teens have more than doubled in recent years, with roughly 22 high-school-age adolescents dying each week from overdoses driven by fentanyl-laced counterfeit prescription pills. National Institutes of Health (NIH) supports development of stronger, longer-acting formulations of opioid antagonists to counteract high-potency synthetic opioids.

Zurnai provides an additional option to address overdoses caused by opioids, both prescription opioids and illicitly manufactured synthetic opioids. Zurnai contains nalmefene, the longest-acting opioid antagonist approved for opioid overdose reversal, in an auto-injector designed to be easy to use. It can be administered by anyone in the community, including healthcare professionals, first responders, as well as bystanders, caregivers, and family members.

Most common adverse reactions that occurred in greater than 5% of subjects were: feeling hot, nausea, headache, dizziness, chills, allodynia, vomiting, palpitations, tinnitus, ear discomfort, feeling abnormal, burning sensation, irritability, hot flush.

Purdue currently distributes, at no profit, nalmefene hydrochloride injection in single-dose vials containing 2 mg/2 mL (1 mg/mL). The vials are for use by healthcare professionals in hospital emergency departments across the country. Healthcare professionals can learn more about nalmefene hydrochloride injection at www.nalmefenehcl.com.