Before month’s end, federal regulators are poised to allow over-the-counter sale of a nasal spray that reverses the potentially lethal effects of an opioid overdose.
Right now, some harm-reduction groups say the discounted price is around $47 for a two-pack of the Narcan brand sprays, doses they hand out to users at no cost. Prices for prescription Narcan vary widely, depending on insurance coverage — at one D.C. chain pharmacy this week, it was selling for $73 without insurance.
Narcan is the nasal spray version of liquid naloxone, and both have emerged as crucial tools in combating opioid overdoses, which kill more than 100,000 people each year in the United States. Naloxone blocks the effects of opioids on the brain, and is safe to use even on someone who is not suffering an overdose. Last month, two advisory committees to the FDA unanimously recommended the agency switch the drug from prescription to over-the-counter.
Narcan’s manufacturer, Emergent BioSolutions, has declined to discuss how much it will charge when the FDA changes its classification so that kits can be stocked on store shelves, possibly by late summer. The Gaithersburg, Md., company insists it will continue to sell discounted sprays to “public interest” customers, such as harm-reduction groups.
Those groups applaud the FDA’s expected move and say it will help, particularly in rural areas and some states where pharmacy restrictions make it more challenging to distribute Narcan on the street. They also believe that having the sprays displayed on the shelves of pharmacies, supermarkets and gas stations — ideally, alongside the aspirin and condoms — will mark a cultural shift, normalizing its use across a broad spectrum of U.S. society.
“It’s not just about accessibility. It also sends a message — we’re trying to remove the stigma around the drug,” said Laura Palombi, a professor of pharmacy and public health at the University of Minnesota in Duluth, Minn.
Stefan Kertesz, an addiction scholar in Alabama, where the drug is harder to come by, agreed that making Narcan more visible to more people might boost its use. “I would love to see a world in which Boy Scouts make handing out naloxone as their Eagle Scout project,” said Kertesz, of the University of Alabama at Birmingham.
How many stores will actually carry the spray, or display it prominently, remains to be seen after the FDA’s expected action. But in many ways, the shift in perception is already happening with the rise in youth overdose deaths, particularly involving fentanyl mixed in pills.
Schools are training parents to use the spray, hoping that the more people who know how to use it and have it on hand, the more lives might be saved. At a forum in Arlington, Va., on Monday, parents heard calls to train students as well. “If we’re teaching our kids how to put condoms on bananas, we can teach them how to put Narcan up somebody’s nose,” a child psychiatrist told parents.
In California, state lawmakers are weighing whether to mandate that schools carry the drug, as the Los Angeles school district is allowing students to carry it on campus.
Narcan is now kept in libraries and airplanes. In Flint, Mich., one vending machine at a bus terminal offering free Narcan dispensed over 500 kits in its first three weeks, according to the county mental health agency.
The Biden administration has called for wider distribution of naloxone, while embracing the strategy of providing drug users with naloxone, along with sterile needles and fentanyl tests strips, to try to save lives.
Harm-reduction groups pursuing those strategies have played the biggest role in distributing naloxone, overcoming a patchwork of state and federal regulations to get it into the hands of those who need it most. Most states now have a system of blanket prescriptions, or “standing orders,” allowing governments, health-care providers and harm-reduction groups to get both liquid and spray naloxone.
An estimated 16.95 million naloxone doses were distributed in 2021, according to a study released this month by the Reagan-Udall Foundation, a nonprofit that advances FDA aims. Almost half of those doses were shared by community groups, governments and other organizations outside retail pharmacies and traditional health-care facilities.
The number of doses was probably even higher last year, according to Remedy Alliance, a nonprofit that has been instrumental in securing naloxone and selling it to harm-reduction groups. The organization, which formerly operated as an informal buyers’ club, launched an online store in 2022 amid manufacturer shortages and gaps in distribution networks across the country.
The FDA in August also made it easier for drug companies to sell discounted naloxone sprays to “public interest” customers, such as harm-reduction groups and state government agencies. Since then, Remedy Alliance has shipped 768,000 more vials of liquid naloxone to groups from its warehouses — 105,774 of them free.
Now, selling Narcan “over the counter will expand the overall pie, we hope,” said Remedy Alliance co-founder Nabarun Dasgupta.
Groups like Remedy Alliance support making the cheaper, injectable naloxone an over-the-counter product as well, something that is not currently under consideration by the FDA.
“Most drug users prefer the needle,” said Miller, of the Twin City Harm Reduction Collective. “Nasal Narcan kind of feels like you got punched in the face after you’ve come to. I’ve been revived with both.”
Still, the more expensive nasal sprays are coveted. Remedy Alliance is now seeking financing to help it purchase the spray kits, so far to no avail, Dasgupta said.
The FDA is also considering granting over-the-counter status to RiVive, a spray manufactured by Harm Reduction Therapeutics, a nonprofit founded to make free or low-cost naloxone available. Co-founder Michael Hufford said if the FDA grants approval by the end of April, he hopes the sprays will debut later this year or in early 2024. He said it costs $18 per unit to manufacture. The company doesn’t have immediate plans to sell it in stores. Instead, supplies will go to harm-reduction groups.
“Our goal is to sell it at cost, or to give it away free to the extent we are able to,” he said.
A few generic naloxone sprays could eventually earn over-the-counter status as well, including ones from companies Teva Pharmaceuticals and Amphastar Pharmaceuticals Inc., which last week got FDA approval for prescription use, although it might take years for those products to make it to store shelves.
Over-the-counter Narcan will be particularly welcomed in states such as Alabama, where it is already available through some online programs but state restrictions make it difficult to hand out on the street.
When people ask for Narcan from harm-reduction group GoodWorks in northern Alabama, founder Morgan Leah steers them out of state, or to a handful of pharmacies if they can afford the prescription price. Because of the stigma of drug use and worries about entering their personal information into government-run websites, many users are reluctant to sign up for Narcan to be delivered in the mail, Leah said.
“And it’s not going to get to you for like a week,” she added.
In northeast Minnesota, Sue Purchase of the small nonprofit Harm Reduction Sisters drives her weather-beaten Honda Fit over snow-covered rural roads delivering naloxone to houses, apartments and trailer communities. Getting the antidote in any form to users in such far-flung areas is challenging, she said.
Harm Reduction Sisters gets free injectable naloxone through Remedy Alliance. Even at the public-interest price, the nasal spray is still too expensive. “There’s not enough Narcan to go around,” Purchase said. “So the [injectable] is primarily what we give.”
One of her volunteers, Delainey Hardy, 45, hopes an over-the-counter nasal spray will soon be made available inexpensively since she prefers them for their ease of use.
She recalls the terrifying moment in 2020 when, for the first time, she had to inject naloxone into her boyfriend Jonathan Cloud, 43, after he overdosed. “You fumble and there’s seconds that go by and there could have been brain damage,” Hardy said. “You’re shaking, and you’ve got to try and put the needle in and hold it still.”
Cloud, who says he has been revived over a dozen times with both nasal and injectable naloxone, hopes the nasal spray will be cheap. “If it’s like five bucks, somebody might spring for it,” said Cloud, who is now in recovery. “But I mean, that’s money that you can use to buy another bag. And when you’re out there using, that’s your primary concern. … just getting that next bag.”
Even if Narcan’s price is initially too expensive for drug users, there will be retail buyers — from parents worried about teen overdoses to occasional drug users worried about pills at a party.
Bonnie Milas, an anesthesiologist who teaches at the University of Pennsylvania and trains the public on Narcan usage, likens keeping the kits on hand to having fire extinguishers.
“There’s lots of things that people put in their homes to provide protection to their family or to any anyone who visits,” she said.
For Milas, the toll of overdoses is real. Two of her adult sons died of accidental opioid overdoses.