Zurnai FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 8, 2024.

FDA Approved: Yes (First approved August 7, 2024)
Brand name: Zurnai
Generic name: nalmefene hydrochloride
Dosage form: Injection
Company: Purdue Pharma L.P.
Treatment for: Opioid Overdose

Zurnai (nalmefene hydrochloride) is an opioid antagonist autoinjector used for the emergency treatment of known or suspected opioid overdose.

• 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. It is not a substitute for emergency medical care.
• Nalmefene hydrochloride is an opioid antagonist first approved by the FDA for opioid overdose as an injection formulation in 1995 under the brand name Revex (now discontinued) and in a nasal spray formulation under the brand name Opvee in 2023. Nalmefene hydrochloride is a 6-methylene analogue of naltrexone, a well established opioid antagonist approved in a number of single ingredient and combination formulations.
• Zurnai works as an antagonist at opioid receptors to reverse the effects of natural and synthetic opioids, including respiratory depression, sedation, and hypotension.
• Zurnai is administered by injection via autoinjector into the outer thigh, through clothing if necessary. Additional doses may be administered (using a new autoinjector for each dose) if the patient does not respond or responds and then relapses into respiratory depression, every 2 to 5 minutes until emergency medical assistance arrives.
• Warnings and precautions associated with Zurnai include the risk of recurrent respiratory and CNS depression; limited efficacy with partial agonists or mixed agonists/antagonists, such as buprenorphine and pentazocine; precipitation of severe opioid withdrawal; risk of adverse cardiovascular effects; and risk of opioid overdose from attempts to overcome the blockade.
• Common adverse reactions (incidence at least 5%) include feeling hot, nausea, headache, dizziness chills, vomiting, allodynia, palpitations, tinnitus, ear discomfort, feeling abnormal, burning sensation, hot flush, and irritability.

Development timeline for Zurnai

Further information

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