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As tens of thousands of people in the United States die of opioid overdose each year, expanding treatment opportunities for persons who are dependent upon either legal or illegal opioids is essential. Better access to the overdose antidote drug naloxone (KLOXXADO, NARCAN, REXTOVY, REVIVE) is a critical part of the response.[1]
First approved by the Food and Drug Administration (FDA) in 1971 as an injectable drug for prescription use only,[2] naloxone acts by displacing opioids from...
As tens of thousands of people in the United States die of opioid overdose each year, expanding treatment opportunities for persons who are dependent upon either legal or illegal opioids is essential. Better access to the overdose antidote drug naloxone (KLOXXADO, NARCAN, REXTOVY, REVIVE) is a critical part of the response.[1]
First approved by the Food and Drug Administration (FDA) in 1971 as an injectable drug for prescription use only,[2] naloxone acts by displacing opioids from receptors in the brain before the sedative effects of opioids can progress to asphyxiation and death. In 2015, the FDA approved naloxone as a prescription nasal spray.[3]
In March 2023, the FDA approved an over-the-counter, 4-milligram (mg) naloxone nasal spray under the brand name Narcan; In July 2023, the agency approved two additional over-the-counter naloxone nasal sprays — a 4-mg generic spray and a 3-mg spray with the brand name ReVive.[4],[5] Soon, these drugs should be widely available at pharmacies for $30 to $50 per two-pack.[6] Although health insurance typically does not pay for over-the-counter drugs, some plans may cover the costs.[7] It will be some time, however, before the effects of over-the-counter naloxone on access to, and affordability of, the drug are known.
Keeping a ready supply of naloxone is recommended for persons (or anyone close to a person) at substantial risk for opioid overdose, including people using opioids illegally (these often contain unexpectedly potent doses of fentanyl) or legally (for example, when buprenorphine or methadone is used to treat substance use disorders). During an overdose, it is highly unlikely that an individual will be able to self-administer naloxone.
Signs of opioid overdose include: unconsciousness or unresponsiveness, shallow breathing, limpness, blue lips, gums or fingertips, slow or irregular heartbeat or pin-point pupils.[8],[9] Naloxone nasal spray should be administered to anyone with a suspected opioid overdose; an additional dose may be necessary if the person does not revive in a few minutes.[10],[11] To administer the spray, insert the tube containing the medication slightly into one nostril of the affected individual and depress the plunger. Immediately after the first dose is administered, call for emergency medical support.
A person revived by naloxone may experience the following opioid withdrawal symptoms: agitation, nausea/vomiting, diarrhea, yawning and tearing/runny nose.[12] Abnormal cardiovascular function, violent behavior and drug craving may also occur.
References
[1] Messinger JC, Beletsky L, Kesselheim AS, et al. Moving naloxone over the counter is necessary but not sufficient. Ann Intern Med. 2023;176(8):1109-1112.
[2] Strang J, McDonald R, Campbell G et al. Take-home naloxone for the emergency interim management of opioid overdose: the public health application of an emergency medicine. Drugs. 2019;79(13):1395-1418.
[3] FDA News Release: FDA approves first over-the-counter naloxone nasal spray. March 29, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-over-counter-naloxone-nasal-spray. Accessed September 18, 2023.
[4] Ibid.
[5] FDA News Release: FDA approves second over-the-counter naloxone nasal spray product. July 28, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-second-over-counter-naloxone-nasal-spray-product. Accessed September 18, 2023.
[6] Ibid.
[7] Facher L. A big insurer decides to cover naloxone for overdose; will others follow? STAT. August 31, 2023.
[8] Food and Drug Administration. Access to naloxone can save a life during and opioid overdose. Undated. https://www.fda.gov/consumers/consumer-updates/access-naloxone-can-save-life-during-opioid-overdose. Accessed September 18, 2023.
[9] Strang J, McDonald R, Campbell G et al. Take-home naloxone for the emergency interim management of opioid overdose: the public health application of an emergency medicine. Drugs. 2019;79(13):1395-1418.
[10] Emergent. Label: naloxone (Narcan). 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208411Orig1s006lbl.pdf. Accessed September 18, 2023.
[11] So many loved one can still be saved. Revive.com. Undated. https://rivive.com/. Accessed September 18, 2023
[12] Strang J, McDonald R, Campbell G et al. Take-home naloxone for the emergency interim management of opioid overdose: the public health application of an emergency medicine. Drugs. 2019;79(13):1395-1418.
