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Opioid Overdose Reversal News: FDA-approved naloxone devices produce substantially higher blood levels of naloxone than improvised nasal spray

Science Spotlight

March 15, 2019

Naloxone Advisory showing inhaler and injection

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.

For a copy of the abstract, published in the Journal of Clinical Pharmacology, go to Comparison of the Pharmacokinetic Properties of Naloxone Following the Use of FDA-Approved Intranasal and Intramuscular Devices Versus a Common Improved Nasal Naloxone Device.

For more information about naloxone and treating opioid overdose, go to: Opioid Overdose Reversal with Naloxone (Narcan, Evzio) and Medications to Treat Opioid Use Disorder.

For more information, contact the NIDA press office at media@nida.nih.gov or 301-443-6245. Follow NIDA on Twitter and Facebook.

NIDA Press Office

About the National Institute on Drug Abuse (NIDA): The National Institute on Drug Abuse (NIDA) is a component of the National Institutes of Health, U.S. Department of Health and Human Services. NIDA supports most of the world’s research on the health aspects of drug use and addiction. The Institute carries out a large variety of programs to inform policy, improve practice, and advance addiction science. Fact sheets on the health effects of drugs and information on NIDA research and other activities can be found at www.drugabuse.gov, which is now compatible with your smartphone, iPad or tablet. To order publications in English or Spanish, call NIDA’s DrugPubs research dissemination center at 1-877-NIDA-NIH or 240-645-0228 (TDD) or email requests to drugpubs@nida.nih.gov. Online ordering is available at drugpubs.drugabuse.gov. NIDA’s media guide can be found at www.drugabuse.gov/publications/media-guide/dear-journalist, and its easy-to-read website can be found at www.easyread.drugabuse.gov. You can follow NIDA on Twitter and Facebook.

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

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    NIDA. (2019, March 15). 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

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