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Drug Overdose Antidote Narcan Goes Over-the-counter
March 29, 2023
David Ovalle

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.”

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.

Attendees to a forum on fentanyl visit a table where Narcan kits were being offered free at Northwood High School in Silver Spring, Md., on Feb. 25. (Michael S. Williamson/The Washington Post)

“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.


Narcan is now for sale without a prescription. Here’s what to know.
September 5, 2023
David Ovalle

Narcan, the nasal spray that reverses opioid overdoses, is hitting store shelves this month for the first time as an over-the-counter medication — a milestone in the fight against the nation’s overdose crisis.

Manufacturer Emergent BioSolutions said last week that it has shipped hundreds of thousands of the two-spray kits, at a suggested retail price of $44.99. Major retailers such as CVS, Rite Aid, Walgreens and Walmart say the kits will be available on shelves in coming days. Companies are also selling the sprays online.

Narcan is a nasal spray version of naloxone, the opioid antidote credited with saving countless lives during the nation’s overdose crisis. More than 110,000 people are believed to have died of drug poisonings last year, more than two-thirds of them from synthetic opioids such as fentanyl. Prescription Narcan is widely used, carried by paramedics and police officers, distributed by groups that work on the streets to reduce the dangers of an increasingly toxic drug supply, and stocked in libraries, schools and even vending machines.

The Food and Drug Administration in March approved Narcan for over-the-counter use, a measure that advocates hope will expand its use by positioning the spray in supermarkets, corner stores and gas stations — and have it stored in first-aid kits or with families worried teens might overdose on counterfeit pills laced with fentanyl.

How does Narcan work?

Naloxone reverses the effects of opioids in the brain, restoring slowed or halted breathing. Narcan is not habit-forming — and is safe to use even in someone who has fallen unconscious but who turns out not to be overdosing on an opioid, said Joshua J. Lynch, associate professor of emergency and addiction medicine at the University at Buffalo.

Don’t test the spray first, Lynch said. “Giving the full vial into someone’s nose — and calling 911 right away — is the best practice,” he said.

Each Narcan pack contains two spray containers each with a four-milligram dose. Experts say it’s crucial to administer naloxone as quickly as possible. A single dose is often enough to restore an overdose victim’s breathing within minutes, although emergency workers have reported using multiple doses to counteract the potency of fentanyl and similar synthetic opioids.

How expensive is Narcan?

Public health experts have long been concerned that over-the-counter Narcan will be too expensive for regular drug users — who are most at risk of overdosing. Still, over-the-counter Narcan for about $45 is an option for people who feel uncomfortable getting the medication from harm-reduction organizations, said Hansel E. Tookes III, an infectious-disease doctor at the University of Miami Miller School of Medicine.

“Of course, I would prefer that the Narcan were cheaper, but $45 to save a human life is a fantastic step in increasing access to lifesaving overdose prevention,” said Tookes, who founded the IDEA Exchange, a Miami program that exchanges used syringes for sterile ones and distributes naloxone to users on the streets.

Most states have used a system that allows Narcan to be dispensed by pharmacists without having to get an individual prescription from a doctor. Narcan going over-the-counter will make it easier to distribute in states with pharmacy restrictions, and advocates believe it will normalize use across a broad spectrum of U.S. society.

Private and public health insurance generally has covered Narcan and liquid naloxone as a prescription medication but can restrict paying for over-the-counter products. In some states such as Massachusetts, some health insurance companies and Medicaid programs have said they will still pay the full cost of over-the-counter Narcan.

The Centers for Medicare and Medicaid Services said it is encouraging state Medicaid programs to cover over-the-counter naloxone.

Coverage under Medicare, the government health insurance program for people 65 and older and for the disabled, is also limited. By law, Medicare Part D can’t cover over-the-counter medications outside of limited exceptions. Medicare Part B will pay for take-home supplies of naloxone provided by programs treating opioid use disorder. Private insurers participating in Medicare Advantage can choose to cover over-the-counter naloxone as supplemental benefit. CMS said it encourages plans to do so.

CVS said it is encouraging customers seeking Narcan to check with pharmacy-counter employees about whether their insurance plan offers savings on prescription naloxone versions.

Health departments, state governments and harm-reduction groups can purchase Narcan under a “public interest” price, which has been lowered to $41 per kit, Emergent said in a news release last week.

Many outreach organizations receive Narcan from government agencies, or rely on cheaper liquid naloxone, which must be administered through a syringe. Harm-reduction groups say scaling up inexpensive liquid naloxone is key to saving lives. Remedy Alliance, a national nonprofit distribution organization, sells the liquid version for under $4 a dose, or gives them away free, to harm-reduction groups that struggle with funding. Remedy Alliance says it has distributed more than 1.5 million doses during the past year.

Where will Narcan be placed in stores?

While many major chains are carrying Narcan, experts worry that customers might still feel embarrassed purchasing the drug because of concerns they will be seen as drug users. “Having it be physically at the counter, or at the pharmacy desk, still presents potential for stigma,” Lynch said.

Walgreens, which operates nearly 9,000 stores, said Narcan will be at the front register and pharmacy counter. Rite Aid said it will be available in the pain care aisle and at the pharmacy counter. Walmart said it will be in “medication aisles in all stories.” CVS said Narcan will be available at pharmacy counters and at front registers.

All four chains said Narcan will be available for purchase online, which can add an extra layer of privacy.

What about other products?

Narcan isn’t the only nasal naloxone spray, and prices figure to drop as more enter the market for prescription and over-the-counter use. The FDA in July approved the first generic over-the-counter nasal spray version of Narcan, manufactured by Padagis.

The federal agency also approved a separate over-the-counter naloxone 3-mg nasal spray, RiVive, made by nonprofit Harm Reduction Therapeutics. The two-spray kits cost $36 to make, according to the company, which said it will prioritize providing RiVive to harm-reduction groups and state governments by early 2024.

The nonprofit has already donated 200,000 doses of RiVive to Remedy Alliance, which will distribute them free of charge to harm-reduction groups across the nation. Eliza Wheeler, the group’s co-founder, called the donation a game changer.

“Harm reduction programs were the original innovators of community-based naloxone distribution 27 years ago, and yet still remain at the margins. We are hopeful that with the availability of RiVive, this will begin to change,” Wheeler said in a statement.