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FDA-Approved Naloxone Devices Produce Higher Blood Levels than Improvised Devices

Improvised devices are typically used as quick-acting options for the untrained

A PPM Brief

Naloxone, an opioid overdose reversal drug injected as a liquid or delivered as a nasal spray, has its fastest administration through an intravenous (IV) dose. However, first responders (such as a family member or friend) are usually not equipped or properly trained to administer the IV quickly in an emergency situation. Many times, first responders use an improvised adaptor to convert liquid naloxone into a rapidly acting nasal spray. A study1 looked at how FDA-approved nasal spray and autoinjector versions of naloxone compared to their improvised nasal device counterparts, which are not yet FDA-approved.

Funded by scientists at the National Institute on Drug Abuse (NIDA), the investigators compared plasma concentrations of naloxone administered once using FDA-approved Narcan 2 mg and 4 mg nasal sprays and Evzio 2 mg autoinjector, compared to results when 2 mg of naloxone was given either once or twice using an improvised device.

Improvised naloxone devices are typically used as quick-acting options for the untrained. (Source: 123RF)

Results indicated that:

  • FDA-approved naloxone devices delivered higher blood levels of naloxone than improvised nasal devices
  • Specifically, 4 mg dose Narcan nasal spray produced the highest blood level of all tested products
  • Levels in the plasma concentration of naloxone are considerably lower when improvised devices are used
  • Six administrations of improvised nasal naloxone devices would be required to reach the naloxone blood levels achieved with one spray of Narcan
  • Researchers suggest that approved naloxone nasal sprays may save more lives than improvised devices.

In other studies cited by the researchers, 90% of participants correctly used FDA-approved devices without training, while fewer than half failed to properly use the improvised nasal spray device, even with training. When deciding on naloxone devices, researchers recommend taking into account both the ease of use and these findings that suggest higher plasma levels of naloxone associated with Narcan compared to improvised devices. Quickly reaching an adequate plasma concentration is critical when treating overdoses involving highly potent opioids such as fentanyl.

Read PPM's ongoing PainScan literature review on Addiction Medicine & Relapse Prevention including perspectives and commentaries on related studies and legislation.

Last updated on: April 15, 2019
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FDA Calls for OTC Naloxone Development
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