Narcan, a prescription nasal spray that reverses opioid overdoses, can now be sold over the counter, the Food and Drug Administration said on Wednesday, authorizing a move long sought by public health officials and treatment experts, who hope wider availability of the medicine will reduce the nation's alarmingly high drug fatality rate.
By late summer, over-the-counter Narcan is expected to be for sale in big-box chains, supermarkets, convenience stores, gas stations and online retailers. New York City plans to install Narcan vending machines later this year. The drug's manufacturer, Emergent BioSolutions, 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.
The FDA commissioner, Dr. Robert M. Califf, said in a statement that the over-the-counter authorization was meant to address a "dire public health need."
"Today's approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it's available and help reduce opioid overdose deaths throughout the country," Califf said. "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."
The Rockville, 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 drug deaths. Emergent won't disclose that price, although groups say it's about $47 for a two-spray kit, down from years past, when discounted Narcan cost $75.
In a statement, the company's president, 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.
Narcan is a nasal spray version of naloxone, a drug that blocks an opioid's effect on the brain. As the overdose crisis has worsened, with more than 100,000 drug-related deaths in the United States for each of the past two years, millions of doses have been administered by outreach workers, health care providers and emergency responders.
But for people who use drugs, as well as for their friends and relatives, ready access to the prescription medication has been elusive.
Naloxone access laws in every state allow pharmacists to have a standing prescription so they can dispense Narcan or a generic brand to anyone who requests it. But many pharmacies choose not to do so, preferring not to engage customers around illicit drug use, especially without a doctor's oversight. Of the nearly 17 million naloxone doses distributed in 2021, only 2.64 million were from pharmacies, according to a recent report.
Public health officials were quick to hail the FDA's authorization, the first time that an overdose reversal spray has been deemed safe for over-the-counter sales. With overdoses and overdose fatalities occurring in college dorms, public libraries, households, nightclubs and restaurants, public health advocates hope that naloxone nasal sprays will soon become a staple of first-aid kits and family medicine cabinets.
"Naloxone can mean the difference between life and death for someone experiencing an overdose and -- as a city and a country -- we have every reason to want people to have it in hand," said Dr. Ashwin Vasan, the health commissioner of New York City. "It is safe and effective, and with increasing fentanyl in our drug supply, we need it everywhere, to save lives." The city provided more than 200,000 Narcan kits to community groups in 2022.
Harm-reduction groups, local health departments and the Biden administration have made the distribution of naloxone a key part of efforts to reduce the staggering number of deaths. Because it's been classified as a prescription drug, most states use a "standing order" system of blanket prescriptions, which allow it to be distributed on the streets, at pharmacies or even through the mail.
Even without needing to get a doctor's prescription, many people have felt reluctant to walk up to a pharmacy counter to ask for the medicine 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.
One reason the FDA approved Narcan for general sales is that it is easy to administer. Bystanders who see that a person slumped over is unresponsive to shaking and shouting, with slowed breathing -- signs of a possible overdose -- only have to unwrap the palm-size device, insert the tip into the person's nostril and depress the plunger. In most situations, the medication revives the person within two or three minutes.
Narcan will not work if the person has taken nonopioid drugs like methamphetamine or xylazine, an animal tranquilizer that has been infiltrating street drug supplies. But addiction experts note that because the supply of illegal drugs has become increasingly tainted with fentanyl, an opioid, there is no downside to using Narcan, regardless of what drug the person was believed to have taken.
Although over-the-counter status will make Narcan more widely available, the cost of the medicine could be a deterrent to many.
Currently, a two-dose pack of prescription Narcan is often free to people covered by Medicaid or private insurance, or has a copay of less than $10. But public and private insurance programs do not cover most over-the-counter medicines. Whether an exception will be made for Narcan could take months to resolve.
This month, a big-box pharmacy in Manhattan was charging $98 for the two-dose box of prescription Narcan to customers without insurance. Another pharmacy chain in New Jersey charged $73.
Emergent BioSolutions has declined to disclose the price it plans for an over-the-counter version, which will take several months to relabel and repackage. On Wednesday morning, after the FDA's announcement, the company released a statement that did not discuss cost.
"We are dedicated to improving public health and assisting those working hard to end the opioid crisis -- so now with leaders across government, retail and advocacy groups, we must work together to continue increasing access and availability, as well as educate the public on the risks of opioid overdoses and the value of being prepared with Narcan to help save a life," Robert G. Kramer, the company's CEO, said in the statement.
In its announcement of the authorization, the FDA acknowledged the concern about price, urging other manufacturers of prescription naloxone to apply for over-the-counter approval, which could make pricing more competitive.
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.
The FDA, for years, 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 for over-the-counter status for Narcan until last fall, prompting questions that it was prioritizing profits over saving lives.
In November, the FDA announced a preliminary assessment that a 4-milligram spray could be safe and effective for nonprescription use. Two FDA advisory panels of experts in February unanimously recommended that Narcan be made 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 spray manufactured by Harm Reduction Therapeutics, a nonprofit that has said it wants to sell its low-cost nasal naloxone to harm-reduction groups at cost, for $18 per unit.
Information for this article was contributed by Jan Hoffman of The New York Times and by David Ovalle of The Washington Post.