In a long anticipated decision, the Food and Drug Administration approved an over-the-counter version of naloxone spray, a generic form of the opioid overdose treatment called Narcan.

Transcript

A MARTÍNEZ, HOST:

People will no longer need a prescription to buy Narcan. That's a nasal spray that reverses opioid overdoses. The Food and Drug Administration announced this morning that it has been approved as an over-the-counter product. NPR pharmaceuticals correspondent Sydney Lupkin is here to tell us all about it. Sydney, it sounds like a pretty big step.

SYDNEY LUPKIN, BYLINE: Yes. Opioid overdoses are a huge public health problem. The deaths keep climbing. According to the National Institutes of Health, there were more than 80,000 opioid deaths in 2021, and that's up from 21,000 in 2010. So they've basically quadrupled. Opioids are deadlier now because of fentanyl, which is highly potent and it's, you know, readily available and flooding the market. Narcan is an effective opioid overdose reversal nasal spray that can be used by health care providers, first responders, family members, you name it.

MARTÍNEZ: And why now?

LUPKIN: The drug maker, Emergent BioSolutions, applied for Narcan to be available without a prescription for any over-the-counter use back in December. And last month, the FDA held a meeting of its advisers - these doctors and other outside experts that aren't in the agency, but they advise it - and they wanted them to weigh the risks and benefits of making this change from prescription to over-the-counter. And those advisers voted unanimously to approve Narcan, which is the brand name for naloxone, for use without a prescription.

They said it can be used safely and effectively without the supervision of a doctor or another health care provider. And the advisers emphasized the need to make sure Narcan is really accessible. With a prescription, that obviously takes time, and there's also stigma. So now it can be sold in gas stations, convenience stores, you know, just about anywhere. And this should hopefully save a lot of people.

MARTÍNEZ: Why did it take so long to weigh those risks?

LUPKIN: So mainly the reason it took so long in general is because a company needed to step forward and give it a try. The FDA can't force a company to make an application. It's this big time-consuming step where the company needs to gather data, show that people can use it safely, and then the FDA has to do its review.

MARTÍNEZ: All right. So how soon then can someone get Narcan at any pharmacy without that prescription?

LUPKIN: It's a great question. So not right away nationally. The FDA says the timeline is really up to the manufacturer and it could take months to make the switch from prescription to over-the-counter. And then the other thing that's up in the air is actually price. It's unclear how much this is going to cost over the counter.

MARTÍNEZ: In the meantime, though, Sydney, what can people do?

LUPKIN: Well, in the meantime, Narcan is available with a prescription, and it's already available in some places for free without a prescription. Public health officials have done what's called a standing order, which is basically a prescription that covers an entire jurisdiction, and that's made the drug widely available in a lot of places. So Baltimore did that, for example. For instance, here in D.C., there's a program for free Narcan pickup or, you know, getting it by mail with discreet packaging.

And there are Good Samaritan laws to protect people seeking and giving help during an opioid overdose. According to GoodRx, there are also three states that provide free Narcan in general. And then cities like Philadelphia and Chicago offer it for free in public libraries. But this new FDA over-the-counter approval would really make it more available everywhere.

MARTÍNEZ: All right. Thanks for the update. That's NPR pharmaceuticals correspondent Sydney Lupkin. Thanks.

LUPKIN: Thank you. Transcript provided by NPR, Copyright NPR.