FDA approves over-the-counter Narcan

The long-simmering opioid crisis came to a boil during the coronavirus pandemic, which catalyzed disease and death, lockdowns, depression, anxiety and lost livelihoods. Hundreds died locally of overdoses, as stress and isolation led some to alcohol and drugs to soothe their physical and emotional pain. 

On Wednesday, the U.S. Food and Drug Administration approved selling naloxone without a prescription, setting the overdose-reversing drug on course to become the first opioid treatment drug to be sold over the counter.

It’s a move that 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.

Here’s a look at the issues involved.

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 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 overdoses, 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, 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.

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 for 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 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. 

"The shift to over-the-counter will definitely make obtaining naloxone much easier for many in our communities. Hopefully, the price will not be a barrier to access, and anyone who would like to obtain naloxone will be able to do so," said Stephen Butkus, a project manager for addiction services and an adjunct at Hofstra University. "With the switch to over-the-counter, it seems like the FDA is hoping to make naloxone available directly to consumers in places like drug stores, convenience stores, grocery stores and gas stations, as well as online.

He added: "As naloxone is the only antidote for an opioid overdose, having more of it readily available in our communities can save a loved-one’s life and give them a second chance.   

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.

WHAT IS THE TIMELINE AND PRICE? 

"The timeline for availability and price of this OTC product is determined by the manufacturer," the FDA said.

With Matthew Chayes