FDA Advisors Recommend Opioid Treatment Narcan for Over-the-Counter Use

The U.S. Food and Drug Administration in White Oak, Md., on July 20, 2020. Sarah Silbiger/Getty Images

An advisory panel to the U.S. Food and Drug Administration (FDA) recommended that the opioid reversal nasal spray Narcan should become an over-the-counter drug.

Narcan, or naxolone, is the most commonly sold medication to deal with opioid overdoses. Emergent BioSolutions Inc. submitted an application to the FDA late last year to allow it to sell generic naloxone hydrochloride without a prescription.

“There is no reason to keep this as a prescription, let’s get it out there and save some lives,” said Elizabeth Coykendall, a paramedic and temporary voting member of the FDA committee, in the panel meeting on Wednesday.

The FDA panel’s vote Wednesday is a recommendation. The drug regulator will have to make the final call on approving Narcan for over-the-counter use in the coming days or weeks.

An FDA official said that Narcan appears to have minimal risks. Other speakers, meanwhile, noted that opioid drug overdoses have skyrocketed in the United States in recent years, namely due to the synthetic drug fentanyl.

“The safety of Narcan nasal spray has been very well established. There appear to be very minimal risks, if any, in terms of unintended effects or unintended serious effects that are worse than the alternative of not treating a patient,” said Maria Coyle, chairwoman of the FDA’s Nonprescription Drugs Advisory Committee. “We, as a committee, appear to be in support of the safety profile.”

Approving the over-the-counter use of naloxone could allow the spray to be distributed to big-box stores and vending machines, said the FDA (pdf) in a report.

If it becomes a nonprescription produce, Narcan “may be sold at many venues besides pharmacies, such as vending machines, convenience stores, supermarkets, [and] big box stores,” the report said.

“Over seven years of having marketed this product, we know that this product is very easy to use. It is being used by a variety of community groups, including lay individuals. It is a single four milligram dose that is safe and effective,” Manish Vyas of Emergent BioSolutions told the panel.

Fentanyl test strips in a container and Narcan at The Legionnaire bar in Oakland, Calif., on March 3, 2022. Nathan Frandino/Reuters

All 50 states, Washington, D.C., and Puerto Rico have laws that allow Narcan to be sold without a prescription at a pharmacy. But it still has to be bought via  a pharmacist, according to a CNN analysis.

According to the updated data provided by the U.S. Centers for Disease Control and Prevention for the year ending in August 2022, fentanyl and other synthetic opioids were involved in about two-thirds of overdose deaths in the country. Over 107,000 people in the United States died of a drug overdose, it said.

However, there has been at least one study, dated in 2018, that suggests Narcan increased reckless opioid usage, emergency room visits, and theft while doing little to curb mortality.

“Broad naloxone access doesn’t seem to be helping and might be making things worse,” University of Virginia researcher Jennifer Doleac told CNBC at the time after laws were passed in some states to make it more readily available. “We don’t have clear answers yet. That’s one of the depressing parts of working on this topic.”

Their paper examined data from 2006 to 2015 and found that after laws made naloxone easier to access, opioid-related emergency room visits and crimes increased. They found that opioid-related deaths increased by 14 percent in Midwest states.

But when their study was published, some researchers said it had critical flaws.

“Given the substantial change in the riskiness of the drug supply, I think the overdose death numbers would have been been substantially higher had we not deployed naloxone to the extent we did,” Chris Jones, the director of the National Mental Health and Substance Use Policy Laboratory, told Stat News at the time.