FDA Approves New Nalmefene Auto-Injector for Opioid Overdose

The U.S. Food and Drug Administration (FDA) has approved a new nalmefene auto-injector called Zurnai, developed by Purdue Pharma LP, to treat opioid overdoses in individuals aged 12 and older. This device delivers a 1.5 mg dose of nalmefene, an opioid receptor antagonist, either subcutaneously or intramuscularly. Available by prescription, Zurnai can quickly reverse life-threatening symptoms of an opioid overdose, such as respiratory depression, sedation, and low blood pressure.

---

Increasing Access to Overdose Reversal Options

The FDA’s decision to approve Zurnai is part of its ongoing effort to expand access to opioid overdose reversal agents. Dr. Robert M. Califf, FDA Commissioner, emphasized that this new product offers an additional method for reversing opioid overdoses, providing more options for emergency treatment.

Clinical Studies and Approval

The approval of Zurnai was supported by safety and pharmacokinetic studies, as well as research conducted on healthy recreational opioid users to evaluate the product’s effectiveness. Common side effects of the treatment include dizziness, nausea, headaches, and other discomforts such as feeling hot or experiencing chills.

Usage Guidelines and Safety Information

Zurnai is specifically contraindicated for patients allergic to nalmefene hydrochloride or any other ingredients in the product. In cases where the overdose involves partial agonists or mixed agonists/antagonists, such as buprenorphine, the reversal may be incomplete, potentially requiring multiple doses of Zurnai.

A New Tool in the Fight Against the Opioid Crisis

Craig Landau, MD, President and CEO of Purdue Pharma, expressed satisfaction with the approval, noting that Zurnai could be a crucial tool for saving lives during opioid overdoses. Purdue Pharma plans to provide Zurnai at no profit as part of its commitment to addressing the opioid crisis.

Background on Nalmefene

The FDA originally approved nalmefene injection in 1995, and the first nasal spray formulation of nalmefene received approval in May 2023. The introduction of Zurnai, which received Fast Track and Priority Review designations, marks the latest advancement in opioid overdose treatment options.

---

References

This article was written based on information provided by Kelli Whitlock Burton, assistant managing editor for Medscape, covering neurology and psychiatry.