FDA Approves First Naloxone Product for Over-the-Counter Use

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The US Food & Drug Administration (FDA) announced that it has approved Narcan for nonprescription, over-the-counter (OTC) use.

Narcan, 4 mg naloxone hydrochloride nasal spray, is the first naloxone product to receive FDA approval for nonprescription use. It quickly reverses the effects of and is the standard treatment for opioid overdose—and now, this decision will make it possible for naloxone to be sold directly to consumers online and in stores.¹

“Naloxone is a critical tool in addressing opioid overdoses and today’s approval underscores the extensive efforts the agency has undertaken to combat the overdose crisis,” said Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, in a press release.¹ “The FDA is working with our federal partners to help ensure continued access to all forms of naloxone during the transition of this product from prescription status to nonprescription/OTC status.”

The American Medical Association (AMA) also released a statement sharing that it “strongly supports” the FDA’s decision.² “While government decisions are often incremental, FDA’s decision will transform how we compassionately and logically respond to the overdose epidemic,” said Bobby Mukkamala, MD, chair of the AMA Substance Use and Pain Care Task Force, in the statement. “More lives will be saved within days of naloxone being easily available at grocery stores and pharmacies. If it weren’t for naloxone, there would be tens of thousands more Americans dying from opioid overdose, including those related to illicitly manufactured fentanyl.”

So, what do psychiatric clinicians think about this decision and how it may affect their patients? “I think this is an important step forward in the management of opioid overdoses, and the drug toxicity crisis, and will allow people with opioid use disorders and their friends and family members to quickly administer nasal spray naloxone in the case of an overdose,” Tony P. George, MD, FRCPC, told Psychiatric Times®. “Getting Narcan over the counter and in this easy-to-administer formulation and available to as many people as possible is a critical step forward in mitigating the opioid crisis in the United States.” 

George is a professor of psychiatry at the University of Toronto; a clinician-scientist at CAMH; a member of the Editorial Board at Psychiatric Times; and coprincipal editor of Neuropsychopharmacology, the journal of the American College of Neuropsychopharmacology.

Thomas R. Kosten, MD, told Psychiatric Times: “Widespread availability of Narcan for community use to reverse opioid overdoses is long overdue in a simple form that requires minimal instruction and is ready for quick action. As a public health measure, its distribution also should be facilitated by inexpensive availability. Because the risk with fatal fentanyl overdoses remains substantial during the current epidemic, the question of whether a single nasal injection will be sufficient for reversal of fentanyl remains a challenge, and perhaps 2 dispensers should be available to every ‘good Samaritan.’ Perhaps more widespread community use will answer that question.”

Kosten is the Jay H. Waggoner Endowed Chair and co-founder at the Institute for Clinical and Translational Research. He is also a professor of psychiatry, neuroscience, pharmacology, and immunology at Baylor College of Medicine in Houston, Texas.

What do you think about the FDA’s decision to approve OTC Narcan? Share your thoughts with us by emailing PTEditor@MMHGroup.com.

References

1. FDA approves first over-the-counter naloxone nasal spray. US Food & Drug Administration. News release. March 29, 2023. Accessed March 29, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-over-counter-naloxone-nasal-spray

2. AMA statement on making naloxone available over the counter. American Medical Association. News release. March 29, 2023. Accessed March 29, 2023. https://www.ama-assn.org/press-center/press-releases/ama-statement-making-naloxone-available-over-counter#:~:text=Mar%2029%2C%202023&text=%E2%80%9CThe%20American%20Medical%20Association%20(AMA,that%20we%20have%20long%20championed