FDA approves over-the-counter Narcan for opioid overdoses. Here’s what that means
The U.S. Food and Drug Administration on Wednesday approved selling naloxone without a prescription, setting the overdose-reversing drug on course to become the first opioid treatment medication to be sold over the counter.
It’s a move that some advocates have long sought as a way to improve access to a lifesaving drug, though the exact impact will not be clear immediately.
Here’s a look at the issues involved.
What is Narcan?
The approved branded nasal spray from Gaithersburg, Md.-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.
The town of Española, N.M., has struggled with drug addiction for generations. But fentanyl has contributed to rising homelessness and overdose rates.
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.
Advocates believe it’s important to get naloxone to the people who are most likely to be around over- doses, including people who use drugs and their relatives.
Police and other first responders also often carry it.
What does the FDA approval mean?
Narcan will become available over the counter by late summer, Emergent BioSolutions said.
With opioid overdoses showing no sign of abating, more regular citizens are carrying Narcan, the medication that can reverse the damaging effects of an overdose.
Other brands of naloxone and injectable forms will not yet be available over the counter, but they could be soon.
The nonprofit Harm Reduction Therapeutics, which has funding from OxyContin maker Purdue Pharma, has an application before the FDA to distribute its version of spray naloxone without a prescription.
How is naloxone distributed now?
Even before the FDA’s action, pharmacies could sell naloxone without a prescription because officials in every state have allowed it.
But not every pharmacy carries it. And buyers have to pay for the medication, either with an insurance co-pay or at the full retail price. The cost varies, but two doses of Narcan often go for around $50.
The drug is also distributed by community organizations that serve people who use drugs, though it’s not easily accessible to everyone who needs it.
Emergent BioSolutions has not announced its price, and it’s not clear yet whether insurers will continue to cover it as a prescription drug if it’s available over the counter.
As California leads the fight to reverse skyrocketing fentanyl overdose deaths, organizations that distribute overdose reversal drugs worry their increasingly bold efforts to save lives will land them in legal trouble.
Does making naloxone available over the counter 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, lead executive officer at Prevention Point Philadelphia, an organization that tries to reduce risk for people who use drugs with services that include 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 and readily access this lifesaving drug,” 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 & Medicaid Services, which now covers prescription naloxone for people on the government insurance programs, says that coverage of over-the-counter naloxone would depend on the insurance program. The agency has not given any official guidance.
Newsom’s education spending plan includes naloxone for all middle and high schools while largely avoiding cuts to school budgets.
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 would 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.
A 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.
Humphreys also said there are fears that if the drug isn’t profitable as an over-the-counter option, the drugmaker could stop producing it.
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