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Drug overdose antidote Narcan goes over-the-counter

The FDA move came as a top Biden official called fentanyl overdose deaths ‘the single greatest challenge we face as a country.'

The FDA approved the over-the-counter sale of the opioid overdose antidote Narcan on Wednesday, a move that will enable people to buy it without a prescription. (Matt Rourke/AP)
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Narcan, the lifesaving nasal spray that reverses opioid overdoses, has been approved for purchase without a prescription, the Food and Drug Administration announced on Wednesday.

The long-awaited decision could dramatically broaden the availability of Narcan, a spray version of naloxone, which requires no special training to administer, and has already been credited with saving thousands of lives from opioid overdoses. The approval came on the same day Homeland Security Secretary Alejandro Mayorkas testified to a Senate panel that the record number of Americans dying of fentanyl overdoses is the “single greatest challenge we face as a country.”

Opioid antidote Narcan can save lives, but sticker shock may stymie over-the-counter sales

The over-the-counter version of Narcan is expected to be made available by late summer, but its long-term impact remains unclear: It will depend on the price set for the spray by its manufacturer, Emergent BioSolutions, and also retailers’ willingness to stock it on store shelves in easy view of consumers. Emergent has yet to disclose how much it will charge for the 4-milligram spray, and public health advocates say too high a price will blunt sales and lessen its lifesaving impact.

“We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price,” FDA Commissioner Robert M. Califf said in a statement.

The Gaithersburg, Md., company has said it will continue to offer Narcan at a discounted “public interest” price for government agencies and nonprofits working to reduce opioid deaths. Emergent won’t disclose that price, although groups say it’s about $47 for a two-spray kit, down from $75 in year’s past.

In a statement, Emergent President and Chief Executive Robert Kramer called the FDA’s decision a “historic milestone.” “We are dedicated to improving public health and assisting those working hard to end the opioid crisis,” he said.

On Wednesday, medical and public health experts urged health insurance plans to cover over-the counter Narcan. The American Medical Association on Wednesday said it hopes the drug is covered at little or no cost to consumers.

“There are many over-the-counter preventive health medications that are covered by insurance, such as aspirin, vitamin D, and fluoride,” Bobby Mukkamala, chair of the group’s substance use and pain care task force, said in a statement. “Naloxone should be added to that list.”

The FDA’s decision comes amid a drug crisis that in 2021 killed about 107,000 people, almost two-thirds of those from illegal fentanyl, the synthetic opioid that is up to 50 times more powerful than heroin and is smuggled across the U.S. border from Mexico. Mayorkas told senators the Biden administration was working with Mexico to “bring the fight to the cartels.”

From Mexican labs to U.S. streets, a lethal pipeline

Harm-reduction groups, local health departments and the administration have made naloxone’s distribution a key part of efforts to reduce the staggering number of deaths. Narcan, as well as the far less-expensive naloxone vials and syringes, are being distributed across the country to drug users on the streets, cops and firefighters, and parents worried their teens may overdose on counterfeit pills containing fentanyl.

Rahul Gupta, director of the White House Office of National Drug Control Policy, called the FDA’s approval an “important step” to widening the drug’s availability. In a statement, he said the administration’s efforts, including allocating money to local health departments to buy the antidote, have “resulted in a decline or flattening of overdose deaths for seven months in a row.”

Since Narcan has been classified as a prescription drug, most states use a “standing order” system of blanket prescriptions, which allow Narcan to be distributed in pharmacies — but people still have to walk up to a pharmacy counter and ask for the spray. Many are reluctant to do that because of the stigma surrounding drug use, said Joshua Lynch, an associate professor of emergency and addiction medicine at the University at Buffalo, who applauded Wednesday’s decision.

“Having Narcan over-the-counter will really open the door for many more people to access it,” Lynch said.

An official of CVS, the nation’s largest pharmacy chain, said Wednesday that it planned to make Narcan available in its more than 9,000 pharmacies across the country. Walgreens, the nation’s second-largest chain, also said it will offer nonprescription Narcan “both in-store and online nationwide,” and is “already working with suppliers to bring this OTC medication to shelves.”

Other pharmacy and supermarket chains did not immediately respond to inquires about their plans to sell the drug, which is generally dispensed in two-spray kits.

Public health experts urged stores to stock it out in the open, rather than behind pharmacy counters or in locked cases.

“People may be embarrassed. They may not want anyone to know they use drugs,” said Sarah Wakeman, medical director for substance use disorder at Mass General Brigham in Boston. “To have it next to Advil, in gas stations and convenience stores, in front of the counter in pharmacies, is incredibly critical.”

Nearly 17 million naloxone doses were distributed in 2021, according to an estimate by the Reagan-Udall Foundation. Last fall, the FDA made it easier for drug companies to sell discounted naloxone to harm-reduction groups. That allowed Remedy Alliance, an umbrella organization that sells the cheaper liquid naloxone to harm-reduction groups, to purchase and ship 768,000 more vials, which must be administered through a syringe.

Nabarun Dasgupta, co-founder of Remedy Alliance, commended the FDA’s move but said liquid naloxone — which costs the organization less than $4 per two-vial kit — should also be made available over the counter. He worries that unless the price for the spray is low enough, much of it may go unsold.

“A lot of naloxone … will expire on shelves and not bring people back from the dead,” said Dasgupta, an epidemiologist at the University of North Carolina at Chapel Hill.

For years, the FDA has sought to widen access to the nasal spray form of naloxone.

In 2019, it created a consumer-friendly “drug facts” label for nasal-spray naloxone, an unusual move designed to encourage companies to seek over-the-counter approval. Emergent did not apply until last fall, however, prompting criticism it was prioritizing profits.

In November, the FDA announced a preliminary assessment that a 4-milligram spray could be safe and effective for nonprescription use. Two independent advisory panels in February unanimously recommended that the FDA make Narcan available over-the-counter, saying the product was safe and easy to use.

Wednesday’s decision is likely to mean that the agency will also approve over-the-counter status for RiVive, a naloxone nasal spray manufactured by Harm Reduction Therapeutics, a nonprofit that wants to sell it to harm-reduction groups at cost, for $18 per unit.

The decision could also pave the way for over-the-counter generic naloxone sprays, which could eventually lower prices. Mukkamala of the AMA urged all naloxone manufacturers to seek over-the-counter approvals. “There is no ethical reason for other manufacturers to delay,” he said.

Nick Miroff contributed to this report.