FDA Approves Nalmefene Injection for Opioid Overdose
Nalmefene injection is an opioid receptor antagonist and comes in a single-dose, pre-filled auto-injector that delivers 1.5 mg of the medication per actuation.
The FDA has approved nalmefene injection (Zurnai) for the emergency treatment of known or suspected opioid overdose caused by natural or synthetic opioids in adult and pediatric patients aged 12 years and older, Purdue Pharma announced in a release.1 Nalmefene injection received both fast track and priority review designations.
FDA Approves Nalmefene Injection for Opioid Overdose / maurice norbert - stock.adobe.com
Nalmefene injection is an opioid receptor antagonist and comes in a single-dose, pre-filled auto-injector. It delivers 1.5 mg of the medication per actuation and is intended for subcutaneous or intramuscular delivery. When administered quickly, it can reverse the effects of opioid overdose, including respiratory depression, sedation and low blood pressure.
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“The FDA remains focused on broadening access to opioid overdose reversal agents, including naloxone and nalmefene,” Robert M. Califf, MD, FDA commissioner, said in a release.2 “[This] approval adds a new nalmefene product and route of administration to support greater options for opioid overdose reversal. Since launching the FDA Overdose Prevention Framework in 2022, the agency continues to build upon efforts that address the overdose crisis currently impacting the nation.”
The approval of nalmefene injection was supported by safety and pharmacokinetic studies. A study was also done to assess how quickly the product works in healthy individuals who use opioids recreationally. The most common adverse reactions of nalmefene use include dizziness, nausea, headache, chills, vomiting, tinnitus, ear discomfort, and burning sensation.
Opioid withdrawal characterized by symptoms including body aches, diarrhea, fast heart rate, fever, runny nose, sneezing, goosebumps, sweating, yawning, nausea or vomiting, nervousness, and restlessness or irritability may occur following nalmefene administration in patients who are opioid-dependent.
Nalmefene injection is only available by prescription. The FDA previously approved nalmefene hydrochloride nasal spray (Opvee) 2.7 mg in May 2023 for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older. It was the first approval of nalmefene hydrochloride nasal spray.3
Purdue said in the release that it currently distributes nalmefene hydrochloride injection in single-dose vials containing 2 mg of the medication to hospital emergency departments across the United States at no profit. The approval of nalmefene injection provides an additional product that is easy to use and can be administered by healthcare professionals, first responders, bystanders, caregivers, and family members.
“We are pleased to gain approval of Zurnai, the nalmefene auto-injector for use by healthcare professionals or anyone in the community,” Craig Landau, MD, president and CEO at Purdue, said in a release.1 “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.”
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