FDA may approve over-the-counter naloxone nasal spray and auto-injectors

Naloxone, packaged with instructions, is one of the items distributed by outreach workers from the Baltimore Harm Reduction Coalition.

Amy Davis | Baltimore Sun | Getty Images

The Food and Drug Administration said Tuesday it may approve over-the-counter nasal sprays and auto-injectors that prevent opioid overdoses, as part of its efforts to expand access to a lifesaving drug called naloxone.

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

“We believe that the prescription requirement for these naloxone products may not be necessary to protect public health,” the agency said in a Federal Register notice released Tuesday, but stressed that it needed more data to draw a definitive conclusion.

Opioid overdose deaths jumped 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 have died from opioids in the United States since 1999 in three waves – first from prescription opioids, then from heroin and more recently 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 renewed the declaration every 90 days since then. The Biden administration extended the emergency again in September.

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

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

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

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