FDA Approves Zurnai Auto-Injector for Opioid Overdose Emergency Treatment
Key Insights
The FDA has approved Zurnai (nalmefene hydrochloride) auto-injector for emergency treatment of known or suspected opioid overdose (search) in adults and pediatric patients aged 12 years and older.
Zurnai delivers 1.5 mg of nalmefene hydrochloride per actuation and is intended for immediate administration in settings where opioids may be present, but it is not a substitute for emergency medical care.
Nalmefene is the longest-acting opioid antagonist approved for opioid overdose (search) reversal, providing an additional option to address overdoses caused by both prescription and illicit synthetic opioids.
The U.S. Food and Drug Administration (FDA) has approved Purdue Pharma L.P.'s new drug application for Zurnai (nalmefene hydrochloride) Auto-Injector, a single-dose auto-injector delivering 1.5 mg of nalmefene hydrochloride per actuation, indicated for the emergency treatment of known or suspected opioid overdose (search) 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 but is not a substitute for emergency medical care.
Addressing the Opioid Overdose Crisis
Provisional data ending February 2024 indicates that approximately 90% of opioid overdose (search) deaths were from synthetic opioids, primarily fentanyl. 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. The National Institutes of Health (NIH) supports the development of stronger, longer-acting formulations of opioid antagonists to counteract high-potency synthetic opioids.
Zurnai: A New Tool for Overdose Reversal
Zurnai provides an additional option to address overdoses caused by opioids, both prescription opioids and illicitly manufactured synthetic opioids. It contains nalmefene, the longest-acting opioid antagonist approved for opioid overdose (search) 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, bystanders, caregivers, and family members.
Clinical Considerations and Adverse Reactions
The most common adverse reactions reported in >5% of subjects were feeling hot, nausea, headache, dizziness, chills, allodynia, vomiting, palpitations, tinnitus, ear discomfort, feeling abnormal, burning sensation, irritability, and hot flush. Zurnai is contraindicated in patients known to be hypersensitive to nalmefene hydrochloride or any other ingredients in the product. A recurrence of respiratory depression is possible, requiring continued surveillance and repeat doses if necessary. The use of Zurnai in opioid-dependent patients may precipitate opioid withdrawal.
Purdue Pharma's Commitment
"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 (search) crisis and are working to provide Zurnai at no profit to the Company."