OTC Narcan: The U.S. Food and Drug Administration (FDA) has approved over-the-counter naloxone, an over-the-counter opioid treatment for the first time.

The U.S. Food and Drug Administration on Wednesday approved naloxone for sale without a prescription, making the drug that reverses overdoses on its way to becoming the first opioid treatment drug to be sold without a prescription.

It’s a move that has long been sought by some advocates as a way to improve access to a life-saving drug, though the exact impact won’t be immediately clear.

Below is a look at related issues.

What is Narcan?

Emergent BioSolutions approved nasal spray from Gaithersburg, Maryland is the most well-known form of naloxone.

It can reverse opioid overdoses, including street drugs like heroin and fentanyl and prescription versions including oxycodone.

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Making naloxone more widely available is seen as a key strategy for controlling the nationwide overdose crisis, which has been linked to more than 100,000 deaths in the United States annually. The majority of these deaths are related to opioids, which are basically strong synthetic versions like fentanyl that can take multiple doses of naloxone to reverse it.

Advocates believe it’s important to get naloxone to people most likely to be near overdoses, including people who use the drug and their relatives.

It is often carried by police and other first responders.

What does FDA approval mean?

The company said Narcan will become available over the counter by late summer.

Other brands of naloxone and the injectable forms will not yet be available over the counter, but they may be available soon.

The nonprofit Harm Reduction Therapeutics, which is funded by OxyContin manufacturer Purdue Pharma, has an application with the Food and Drug Administration to distribute its over-the-counter spray version of naloxone.

How is naloxone distributed now?

Even before the FDA’s action, pharmacies could sell naloxone without a prescription because officials in every state allowed it.

But not every pharmacy carries it. Buyers have to pay for the drug—either through an insurance co-pay or at full retail price. The cost varies, but two doses of Narcan often cost around $50.

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

Emergent hasn’t announced its price and it’s not yet clear if insurance companies will continue to cover it as a prescription drug if it’s available over the counter.

Does over-the-counter naloxone improve access?

It paves the way for Narcan to be available where there are no pharmacies – convenience stores, supermarkets and online retailers, for example.

It can help a lot for people who don’t seek services — or who live in places where they don’t, said Jose Benitez, chief executive officer at Prevention Point Philadelphia, an organization that tries to reduce the risk of people using drugs with services including free naloxone distribution. In which.

Now, he said, some people worry about getting naloxone at pharmacies because their insurance companies will know they’re getting it.

“Taking it off the shelves would allow people to just pick it up, not have a stigma attached to it and easily get access to this life-saving drug,” he said.

But it remains to be seen how many stores it will offer and what the prices will be. The US Centers for Medicaid and Medicare, which now covers naloxone prescriptions for people on state insurance programs, says over-the-counter naloxone coverage will depend on the insurance program. The centers did not provide any official guidance.

Maya Doe-Simkins, co-director of the Remedy Alliance/For The People, which launched last year to provide low-cost — sometimes free — naloxone to community organizations, said her group will continue to distribute injectable naloxone.

Are there disadvantages to selling without a prescription?

One concern, said Keith Humphreys, an addiction expert at Stanford University, is whether people who buy Narcan without a prescription will know how to use it properly, even though the manufacturer is responsible for clear directions and online videos about that.

One of the benefits of getting pharmacists involved, he said, is that they can show buyers how to use it. One of the main things to remind people of: Call an ambulance for the person receiving naloxone after it has been given.

He also said there are concerns that if the drug is not profitable as an over-the-counter option, the drug company may stop producing it.

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