FDA-Approved Naloxone Devices Produce Substantially Higher Blood Levels of Naloxone than Improvised Nasal Spray

By National Institute on Drug Abuse

Naloxone is a potentially life-saving drug commonly used to reverse opioid overdoses and can be injected as a liquid or delivered as a nasal spray. The fastest method of delivery is through an intravenous (IV) dose, but many first responders, police, families or friends are not well equipped or trained to quickly administer an IV in an emergency situation. Historically, many first responders have used an improvised adaptor to convert the liquid product into a rapidly acting nasal spray. However, in recent years the Food and Drug Administration (FDA) has approved an autoinjector device as well as an intact nasal spray technology.

A new study looked at how well the FDA-approved nasal spray and autoinjector compared to the improvised nasal devices, which are not FDA-approved. Scientists found that the approved naloxone devices deliver higher blood levels of naloxone than the improvised nasal devices. In fact, levels in the plasma concentration of naloxone are considerably lower when improvised devices are used. The FDA-approved 4-mg dose nasal spray produced the highest blood level of naloxone of all the products tested. There are many variables associated with the successful use of naloxone, but quickly reaching an adequate plasma concentration is especially critical when treating overdoses involving highly potent opioids, such as fentanyl. These outcomes suggest that the approved nasal spray technology has the potential to save more lives than improvised devices. The research was funded by scientists at the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health.

The investigators compared plasma concentrations of naloxone when it was administered once using the FDA-approved Narcan® 2-mg and 4-mg nasal spray devices and the Evzio® 2-mg Autoinjector. These results were compared to results when 2 mg of naloxone was given either once or twice using the improvised device. Findings suggest that six administrations of the improvised nasal naloxone device would be required to reach the naloxone blood levels that are achieved with one spray of the nasal Narcan brand product.

Citing other studies, researchers noted that 90% of participants correctly used the FDA-approved devices without training, while fewer than half fail to properly use the improvised nasal spray device even with training. When deciding which naloxone nasal spray device to use, the researchers recommend taking into consideration the ease of use and higher plasma levels of naloxone associated with the FDA-approved Nasal Narcan® device compared to the improvised device.

NIDA contributed to the development of the FDA-approved nasal spray formulation, but the institute is not associated with commercial distribution of the product.

NIDA. (2019). Opioid overdose reversal news: FDA-approved naloxone devices produce substantially higher blood levels of naloxone than improvised nasal spray. Retrieved from https://www.drugabuse.gov/news-events/news-releases/2019/03/opioid-overdose-reversal-news-fda-approved-naloxone-devices-produce-substantially-higher-blood-levels-of-naloxone-than-improvised-nasal-spray


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