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Narcan approved for over-the-counter sale

The opioid overdose-reversing nasal spray should be available for purchase without prescription in late summer

by Shi En Kim
April 4, 2023


Product image of Narcan nasal spray
Credit: VCU Capital News Service/Flickr
Narcan, a nasal spray formulation of naloxone, just received the nod for over-the-counter sale.

On Mar 29, the US Food and Drug Administration approved the opioid overdose-reversing nasal spray Narcan for over-the-counter sales. Narcan’s developer, Emergent BioSolutions estimates that the product will be available without prescription online and in stores nationwide by late summer.

Chemical structure of naloxone

An increase in the availability of Narcan is a welcome development, says Kathryn Hawk, an emergency physician and addiction researcher at Yale School of Medicine. “Anything that increases access to naloxone in the community is a win.” The only concern she has is whether Narcan’s newly minted status will affect the cost and insurance coverage of other opioid overdose-reversing formulations.

The death rates for drug overdoses in the US have skyrocketed in recent years, driven, in particular, by opioid use. The potent synthetic opioid fentanyl, which can be consumed knowingly or unknowingly as a contaminant of other street drugs, is a primary contributor to these deaths. “It only takes two milligrams [of fentanyl] to kill a person,” says Donna Nelson, a chemist at the University of Oklahoma. She likens the act of taking street drugs to “playing Russian roulette.” Nelson is organizing a session on the dangers of fentanyl at the American Chemical Society’s Fall Meeting. (ACS publishes C&EN).

Naloxone, the active ingredient in Narcan, works by displacing opioids from their receptors and binding there instead without producing the same high. The drug first debuted on the market as an injectable in the 1970s. As a nasal spray, Narcan was designed be easier to administer than via a syringe, and it gained regulatory approval for prescription use in 2015.

Naxolone products have gotten around the prescription barrier in the past through a patchwork of state laws, standing orders, and collaborative practice agreements among pharmacists. Some harm reduction groups have also distributed these opioid overdose-reversers for free in local communities.

For a drug to gain nonprescription status approval, manufacturers need to demonstrate that their product is safe and can be used without supervision from a healthcare professional. Hawk thinks that the needle-free Narcan lends itself well to over-the-counter access, given its user friendliness. For this reason, she doesn’t expect naloxone injectables to switch to nonprescription status any time soon, unless companies pursue this option. Autoinjector naloxone products may be easier to deploy than traditional syringes, but their much higher costs don’t make them nearly as attractive for widespread use, she says.



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