The U.S. Food and Drug Administration on Wednesday approved selling the overdose antidote drug naloxone over the counter, putting it on course to be the first opioid treatment sold without a prescription.
The spray version, sold under the brand name Narcan, will be available for sale by late summer, according to the drug’s manufacturer, Emergent BioSolutions.
Doctors praised the move to make naloxone more accessible as the national opioid crisis continues, but they are concerned the drug could be too expensive without a prescription.
“This is a great step in making naloxone more available. It’s a critical tool for overdose prevention,” said Dr. Juleigh Nowinski-Konchak of Cook County Health.
The move could make the antidote available at corner stores, grocery stores and even vending machines, she said.
But it’s is not enough to address the national overdose crisis, she said. Overdose deaths in Cook County have broken records yearly since 2018. Last year, more than 2,000 people died from overdoses, according to the Cook County medical examiner’s office.
Naloxone “is a critical tool, but we also need other tools like overdose prevention sites, easier access to methadone, pass drug de-felonization and other levers as well,” Nowinski-Konchak said.
Walgreens said it’s already in talks with the drug’s manufacturer to sell the drug over-the-counter later this year.
It’s still unclear how much the drug will cost.
“It’s possible prices may be inflated — $75, $100,” said Amit Gupta, a physician at Loyola University Medical Center’s emergency department. Prescription naloxone is typically covered by Medicaid and private insurers, or is the cost of a $10 copay. But it’s unclear if Medicaid and other insurers will cover the over-the-counter version.
Narcan was first approved as a prescription drug by the FDA in 2015, and was deemed safe enough to be considered for over-the-counter status in November last year. Narcan’s manufacturer then applied for OTC status with the FDA.
“This is long overdo,” Gupta said. Naloxone works by blocking opioid receptors in the brain, and has minimal side effects on accidental ingestion, even by children, he said.
Erik McIntosh, a professor at Rush University, has been advocating for access to naloxone on the CTA after witnessing an overdose on a Blue Line train last year.
“How we have AED’s available across the community (for heart attacks), that’s how Narcan should be,” he said.
The move to over-the-counter status could also chip away the stigma attached to naloxone, whether that’s because it’s associated with substance abuse or that people are unsure of how to use it.
“Having it right there at the counter, available without a prescription, will hopefully reinforce that,” Nowinski-Konchak said.
The antidote will also be more accessible to parents or partners of people suffering from substance abuse, who may not be aware of the options already available to them.
“The more choices people have, the better,” said Karen Bigg, director of community outreach at Chicago Recovery Alliance, which distributes naloxone and clean needles on the South and West sides of Chicago.
A potential drawback could be that some people may no longer get instructions from pharmacists, Bigg said. But the over-the-counter version of Narcan, which is sprayed into someone’s nose, is easy enough to use by following the written directions, she said.
Although the FDA had previously labeled naloxone as prescription only, every state in the country has laws that make it accessible without prescriptions in certain instances. In Illinois, naloxone was already available without a prescription at needle exchanges, health departments and the Chicago Public Library.
What is Narcan?
The approved nasal spray from Gaithersburg, Maryland-based Emergent BioSolutions is the best-known form of naloxone.
It can reverse overdoses of opioids, including street drugs such as heroin and fentanyl, and prescription versions, including oxycodone.
Making naloxone available more widely is seen as a key strategy to control the nationwide overdose crisis, which has been linked to more than 100,000 U.S. deaths a year. The majority of those deaths are tied to opioids, primarily potent synthetic versions such as fentanyl that can take multiple doses of naloxone to reverse.
The drug has been distributed to police and other first responders nationwide.
Advocates believe it’s important to get naloxone to the people who are most likely to be around overdoses, including people who use drugs and their relatives.
The decision “represents a decisive, practical and humane approach to help people and flatten the curve of overdose deaths,” said Chuck Ingoglia of the National Council for Mental Wellbeing, in a statement.
What does the FDA approval mean?
Narcan will become available over the counter by late summer, the company said.
Other brands of naloxone and injectable forms will not yet be available over the counter, but they could be soon.
Several manufacturers of generic naloxone that’s made similarly to Narcan will now be required to file applications to switch their drugs to over the counter as part of a requirement by the FDA.
The nonprofit Harm Reduction Therapeutics Inc., which has funding from OxyContin maker Purdue Pharma, already has an application before the FDA to distribute its version of spray naloxone without a prescription.
Does making naloxone an over-the-counter drug improve access?
It clears the way for Narcan to be made available in places without pharmacies — convenience stores, supermarkets and online retailers, for instance.
Jose Benitez, the lead executive officer at Prevention Point Philadelphia, an organization that tries to reduce risk for people who use drugs with services, including handing out free naloxone, said it could help a lot for people who don’t seek services — or who live in places where they’re not available.
Now, he said, some people are concerned about getting naloxone at pharmacies because their insurers will know they’re getting it.
“Putting it out on the shelves is going to allow people just to pick it up, not have stigma attached to it,” he said.
But it remains to be seen how many stores will carry it and what the prices will be. The U.S. Centers for Medicare and Medicaid Services, which now cover prescription naloxone for people on government insurance programs, said that coverage of over-the-counter naloxone would depend on the insurance program. The centers have not given any official guidance.
Maya Doe-Simkins, a co-director of Remedy Alliance/For The People, which launched last year to provide low-cost — and sometimes free — naloxone to community organizations, said her group will continue to distribute injectable naloxone.
Are there drawbacks to over-the-counter sales?
One concern is whether people who buy Narcan over-the-counter will know how to use it properly, said Keith Humphreys, a Stanford University addiction expert, though the manufacturer is responsible for clear directions and online videos on that.
One benefit of having pharmacists involved, he said, is that they can show buyers how to use it. One key thing people need to be reminded of: Call an ambulance for the person receiving naloxone after it’s been administered.
He also said there are fears that if the drug isn’t profitable as an over-the-counter option, the drugmaker could stop producing it.
Contributing: AP
