The U.S. Food and Drug Administration (FDA) has approved Zurnai, a groundbreaking nalmefene hydrochloride auto-injector designed for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients aged 12 years and older. This approval follows the agency’s earlier authorization of the first nasal spray formulation of nalmefene in May 2023.
Opioid Overdose Crisis
Drug overdose remains a critical public health issue in the United States, with over 107,000 reported fatal overdoses occurring in 2023. The rise in fatalities is primarily driven by synthetic opioids, including illicit fentanyl. To combat this crisis, the FDA has been actively working to enhance the availability and accessibility of overdose reversal agents.
Nalmefene: A Vital Tool
Nalmefene is an opioid receptor antagonist used to treat acute opioid overdose. When administered promptly, it can reverse the effects of overdose, including respiratory depression, sedation, and low blood pressure (hypotension). Zurnai delivers 1.5 milligrams (mg) of nalmefene either subcutaneously or intramuscularly via a single-dose, pre-filled auto-injector. It is available exclusively by prescription.
Safety and Efficacy
The approval of Zurnai is backed by rigorous safety and pharmacokinetic studies. Additionally, a study involving healthy individuals who recreationally use opioids assessed the product’s rapid action. Common adverse reactions include feeling hot, dizziness, nausea, headache, chills, vomiting, and allodynia (feeling pain from actions that aren’t typically painful).
A Step Forward
FDA Commissioner Robert M. Califf, M.D., emphasized the agency’s commitment to broadening access to opioid overdose reversal agents. Zurnai’s approval represents a significant advancement in providing more options for opioid overdose reversal, aligning with the FDA’s ongoing efforts to address the national overdose crisis.