The FDA can approve over-the-counter naloxone nasal sprays and auto-injectors

Naloxone, packaged with instructions, is one of the products being given out by the Baltimore Harm Reduction Coalition outreach workers.

Amy Davis | Baltimore Sun | Getty Images

The Food and Drug Administration said Tuesday it could potentially approve over-the-counter nasal sprays and auto-injectors that prevent opioid overdoses, part of its effort to expand access to a life-saving drug called naloxone.

The FDA said in a preliminary review that nasal sprays containing up to 4 mg of naloxone and auto-injectors that deliver a dose of up to 2 mg of the drug could be safe and effective for people to self-administer without a prescription.

“We believe that prescription requirements for these naloxone products may not be necessary to protect public health,” the agency said in a federal registry release released Tuesday, but stressed that it needs more data to reach a definitive conclusion.

The number of opioid overdose deaths rose 65% during the Covid-19 pandemic from 47,000 in 2019 to nearly 78,000 in 2021, according to data from the Centers for Disease Control and Prevention. More than 564,000 people in the US have died from opioids in three waves since 1999—first from prescription opioids, then from heroin, and finally from fentanyl.

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The Trump administration declared the opioid crisis a public health emergency in 2017. The Department of Health and Human Services has since renewed the statement every 90 days. The Biden administration extended the state of emergency again in September.

FDA Director Robert Califf said in a statement Tuesday the regulator is looking at ways to prevent opioid-related deaths by expanding access to naloxone. The FDA encourages manufacturers to submit applications for non-prescription use of naloxone products.

Naloxone is a drug that quickly reverses overdoses by binding to opioid receptors. It can quickly restore normal breathing to someone who is either breathing slowly or not at all due to an opioid overdose, according to the National Institute of Drug Abuse.

The FDA first approved a single-use naloxone auto-injector called Evzio in 2014 and a single-dose nasal spray called NARCAN in 2015. Both require a prescription.