SafeX Pro:A major drugmaker plans to sell overdose-reversal nasal spray Narcan over the counter

Drug maker Emergent BioSolutions is SafeX Proseeking approval from the Food and Drug Administration to sell Narcan over the counter, without need for a prescription.

The medication, an easy-to-use nasal spray version of the drug naloxone, has a strong track record reversing deadly opioid overdoses, which have soared in recent years largely because of the spread of fentanyl.

"I think it's a wonderful thing," says China Darrington, an addiction counselor in Ohio who was herself addicted to heroin for 16 years.

"The potency of the drugs nowadays is just so unfair. Naloxone has got to be around. People have got to have access to it."

Darrington tells NPR she survived addiction because people happened to have Narcan on hand when she overdosed.

"I've experienced being Narcaned, I want to say, about a half dozen times in my life. It kept me alive. You have to give people a chance to stay alive," she says.

It's a wonder drug for opioid overdoses but often unavailable

During severe opioid overdoses, people stop breathing and die. Narcan and other forms of naloxone quickly reverse those harmful effects.

But right now the medication is often hard to get, with access complicated by a dizzying patchwork of state and federal laws.

Speaking at a press conference this month, Dr. Rahul Gupta, head of the White House Office of National Drug Control Policy, pointed out that last year alone roughly 80,000 Americans died from opioid overdoses.

With naloxone on hand, many of those deaths would have been avoided.

"There is today no excuse, no excuse absolutely for not having it everywhere available, when we know that's one medication that can save tens of thousands of lives right now," Gupta said.

Emergent BioSolutions CEO Bob Kramer says the FDA has now agreed to fast track its application to sell Narcan over the counter without a prescription, with an answer expected by the end of March.

"We see this as a significant step forward for Narcan and naloxone," Kramer tells NPR in an interview.

Saving lives with one-spritz of medication

Kramer says the goal is to have Narcan so widely available that it's everywhere, ready in people's purses, in school classrooms, in shops and businesses, whenever someone overdoses.

"It's very easy to administer," he says. "You place the device in the nostril in the nostril and you deploy the mechanism with a puff."

Drug policy experts contacted by NPR agreed making Narcan widely available is an important next step to reduce drug deaths. But they also raised one fear.

"I am very concerned about the price," says Nabarun Dasgupta, drug researcher at the University of North Carolina who also works with a nonprofit that distributes free naloxone to active drug users.

Widely available. But also affordable?

Emergent BioSolutions hasn't yet set a price for the non-prescription version of Narcan. Dasgupta says if it's too expensive, many people at risk of overdose just won't buy it.

"If we have this resource scarcity mentality, that this is an expensive product, then people will not take enough kits to do what they need to do," he says.

In much of the country, governments, insurance companies and nonprofit groups now subsidize naloxone distribution. It's not yet clear how that system will be affected once Narcan is on pharmacy shelves.

One hope is that prices will fall as other drug companies that make naloxone products also seek permission to sell their medications without a prescription.

FDA Commissioner Robert Califf signaled this month his agency plans to approve those applications when they're submitted.

"We think it is time to move to over the counter naloxone," he said at a press conference.