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The Food and Drug Administration on Wednesday approved selling the overdose-reversal drug Narcan without a prescription, a move long sought by advocates to improve access to the life-saving drug.
The approval would make the nasal spray used to counteract fentanyl and opioid overdoses more accessible to consumers who could buy the medication at stores without a prescription or pharmacist’s recommendation.
FDA Commissioner Robert Califf urged the drug’s manufacturer to make Narcan widely available at an affordable price.
“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 in a statement.
Here’s a look at the issues involved.
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What is Narcan?
The approved branded 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 illicitly manufactured fentanyl that can take multiple doses of naloxone to reverse.
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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.
Narcan and its generic version, naloxone, is widely distributed by community organizations that seek to slow the nation’s spiraling overdose epidemic. Community health departments, schools, police and fire departments often carry the drug.
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.
The nonprofit Harm Reduction Therapeutics Inc., which has funding from OxyContin maker Purdue Pharma, has an application before the FDA to distribute its version of spray naloxone without a prescription.
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How is naloxone distributed now?
All states have standing orders that allow a person to get naloxone from a pharmacist without a doctor’s prescription, but consumers must approach a pharmacist and ask for the medication before purchasing.
But not every pharmacy carries it. And buyers have to pay for the medication – either with an insurance co-pay or for the full retail price. The cost varies, but two doses of Narcan often go for around $50.
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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 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.
Does making naloxone 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, 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.
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Now, he said, some people are concerned about getting naloxone at pharmacies because their insurers will know they’re getting it.
“Putting it out of the shelves is going to allows people just to pick it up, not have stigma attached to it and readily access this life-saving drug,” he said.
But it remains to be seen how many stores will carry it and what the prices will be. The Centers for Medicaid and Medicare Services covers prescription naloxone for people on the government insurance programs for older adults and low-income families. CMS has not offered any official guidance on whether it will cover retail versions.
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.
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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.
One benefit of having pharmacists involved, he said, is 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; Associated Press
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