FDA approves overdose-reversing Narcan for sale without prescription

The US 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 drug to be sold over counters in the US.

It is a move some advocates have long sought as a way to improve access to a life-saving drug, though the exact impact will not be clear immediately.

The best-known form of naloxone is Narcan, an approved branded nasal spray made by Emergent BioSolutions in Gaithersburg, Maryland. 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 US overdose crisis, which has been linked to more than 100,000 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 is important to get naloxone to people who are most likely to be around overdoses, including people who use drugs and their relatives. Police and other first responders often carry it.

Emergent BioSolutions said Narcan would become available over-the-counter by late summer. Other brands of naloxone and injectable forms will not yet be available over the counter, but could be soon.

Harm Reduction Therapeutics, a non-profit which has funding from the OxyContin maker Purdue Pharma, has an application before the FDA to distribute its version of spray naloxone without a prescription.

The drug is also distributed by community organizations that serve people who use drugs, though it is not easily accessible to everyone who needs it.

Emergent has not announced its price and it is not clear yet whether insurers will continue to cover it as a prescription drug if it is available over the counter.

However, the FDA decision clears the way for Narcan to be made available in places without pharmacies, including convenience stores, supermarkets and online retailers.

Now, he said, some people are concerned about getting naloxone at pharmacies because their insurers will know they are getting it.

The US Centers for Medicaid and Medicare Services, which now covers prescription naloxone for people on government insurance programs, says coverage of over-the-counter naloxone would depend on the insurance program. It has 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 would continue to distribute injectable naloxone.

One concern is whether people who buy Narcan over the counter will know how to use it, 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, Humphreys said, is that they can show buyers how to use it. Humphreys also said there are fears that if the drug is not profitable as an over-the-counter option, the drugmaker could stop producing it.