FDA Approves Nalmefene Auto-Injector to Reverse Opioid Overdose

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Paramedics helping a patient on stretcher inside ambulance

On August 7, 2024, the U.S. Food and Drug Administration (FDA) approved Purdue Pharma's Zurnai® (nalmefene) autoinjector for emergency treatment of opioid overdose in individuals aged 12 years and older.

Nalmefene, an opioid receptor antagonist, reverses overdose effects like respiratory depression, sedation, and hypotension. The drug is noted for its rapid onset and longer duration of action compared to naloxone, especially against synthetic opioids.

The recommended dose of Nalmefene is 1.5 mg administered subcutaneously (SC) or intramuscularly (IM), followed by immediate contact with emergency services. Additional doses may be given every two to five minutes until help arrives.

Zurnai will be available by prescription, but pricing and availability details are pending. It was granted fast track and priority review designations to expedite the approval process.

Opioid overdose, including synthetic opioids like fentanyl, continues to be a significant public health issue, with over 107,000 deaths in 2023. Other available opioid overdose treatments include single-dose vials of nalmefene for injection (re-entered the market in 2022), Opvee® (nalmefene – Opiant Pharmaceuticals) nasal spray and naloxone (nasal spray, injectable, and over-the-counter formulations).

MyMatrixx Actions

MyMatrixx is dedicated to helping our clients monitor and manage the cost and utilization of opioids within their claims. We will continue to evaluate Zurnai to determine if it is an appropriate addition to our formularies. If you have any questions, please reach out to your MyMatrixx account team.