FDA approves an OTC Narcan

This life-saving medication will be available without a prescription by late summer 2023

This week the U.S. Food and Drug Administration (FDA) approved a non-prescription version of Narcan (naloxone), a nasal spray used to rapidly reverse the effects of an opioid overdose. This marks the first time an over-the-counter version of this life-saving medication will be available. 

“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 statement released Mar. 29.

According to the FDA, drug overdose is a persistent public health problem in the United States. More than 101,000 fatal overdoses were reported between October 2021 and October 2022. Many of them were caused by synthetic opioids such as fentanyl, including illicit fentanyl. The National Institute on Drug Abuse notes that even a small dose of fentanyl can be lethal. 

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When administered, Narcan goes to work quickly by binding with the same receptors in the brain that opioids bind with. According to the manufacturer, it only takes two to three minutes to reverse the effects of the overdose. It’s still important, however, to call for emergency medical help after administering Narcan, even if the person wakes up. 

Why this product matters

Naloxone has long been available in an injectable form; it received FDA approval in 1971 for the treatment of overdoses. The Narcan nasal spray, manufactured by Emergent BioSolutions, wasn’t granted FDA approval until 2015—but access was restricted to those with a prescription. 

“Making naloxone available without a prescription makes it accessible to everyone, which is incredibly important, given the amount of fentanyl that has tainted just about all illegally obtained drugs,” says Erika Gray, Pharm.D., chief medical officer of Toolbox Genomics.

But, the use of Narcan isn’t just for those using illicit substances. “Anyone who is using opioids, even under a doctor’s orders, is at risk for overdosing,” says Suzanne Robotti, a member of the FDA’s Drug Safety and Risk Management Advisory Committee. “If there are opioids in the home, you should have naloxone also.” Over-the-counter availability makes this much more easily attainable.

When will naloxone OTC be available?

The manufacturer said in a statement that Narcan OTC is expected to be available in late summer 2023. This delay allows time for manufacturing changes for nonprescription packaging and supply chain modifications. The OTC version of the nasal spray will be available in a 4 mg dose.

“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,” Dr. Cavazzoni said. “Further, we will work with any sponsor seeking to market a nonprescription naloxone product, including through an Rx to OTC switch, and encourage manufacturers to contact the agency as early as possible to initiate discussions.”

How much will naloxone OTC cost?

Emergent BioSolutions has not yet announced a price for naloxone OTC nasal spray. Some experts worry that cost will restrict access since insurance companies often do not offer coverage for OTC meds.

“We must ensure that the cost of Narcan OTC is not a barrier for those who need it most and that it is widely accessible across all communities,” says Clare Waismann, an addiction specialist and founder of a detox center in California. “It is crucial that we continue to work toward making Narcan available and affordable to everyone, regardless of their economic status or location.”

If you’re concerned about naloxone cost, you can use prescription savings cards, like SingleCare. Or, many city and county health departments provide access to this medication for free.



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