FILE - The overdose-reversal drug Narcan is displayed during training for staff members of the general public Health Management Corporation (PHMC), Dec. 4, 2018, in Philadelphia. The U.S. Food and Drug Administration has authorized offering overdose remedy naloxone over-the-counter, Wednesday, March 29, 2023, marking the very first time a opioid treatment drug will be offered without a prescription. (AP Photo/Matt Rourke, File).
Credit: ASSOCIATED PRESS.
( AP Photo/Matt Rourke, File).



BY ASSOCIATED PRESS.

The U.S. Food and Drug Administration on Wednesday approved offering naloxone without a prescription, setting the overdose-reversing drug on course to end up being the first opioid treatment drug to be sold over the counter.

It's a relocation that some supporters have long sought as a method to enhance access to a life-saving drug, though the specific effect will not be clear right away.

Here's a look at the concerns included.

WHAT IS NARCAN?

The approved top quality 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 readily available more commonly is seen as a crucial technique to manage the across the country overdose crisis, which has been connected to more than 100,000 U.S. deaths a year. The majority of those deaths are connected to opioids, mostly potent synthetic variations such as fentanyl that can take multiple dosages of naloxone to reverse.

Advocates believe it's crucial to get naloxone to the people who are probably to be around overdoses, consisting of individuals who use drugs and their relatives.

Police and other first responders likewise frequently carry it.

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WHAT DOES THE FDA APPROVAL MEAN?

Narcan will appear over the counter by late summer, the company said.

Other brands of naloxone and injectable forms will not yet be readily available nonprescription, but they could be quickly.

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.

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HOW IS NALOXONE DISTRIBUTED NOW?

Even before the FDA's action, drug stores might sell naloxone without a prescription since officials in every state have enabled it.

Not every drug store carries it. And purchasers have to pay for the medication-- either with an insurance co-pay or for the full list price. The expense varies, but two dosages of Narcan typically go for around $50.

The drug is also dispersed by community organizations that serve people who utilize drugs, though it's not quickly available to everybody who requires it.

Emergent has actually not announced its rate and it's not clear yet whether insurance providers will continue to cover it as a prescription drug if it's offered nonprescription.

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DOES MAKING NALOXONE OVER-THE-COUNTER IMPROVE ACCESS?

It clears the way for Narcan to be made offered in places without drug stores-- convenience stores, grocery stores and online sellers.

Jose Benitez, the lead executive officer at Prevention Point Philadelphia, an organization that tries to decrease threat for people who use drugs with services including giving out totally free naloxone, said it might assist a lot for people who do not look for services-- or who reside in locations where they're not offered.

Now, he stated, some people are worried about getting naloxone at drug stores because their insurance companies will understand they're getting it.

" Putting it out of the shelves is going to enables individuals simply to select it up, not have actually stigma connected to it and readily access this life-saving drug," he said.

But it stays to be seen the number of shops will bring it and what the prices will be. The U.S. Centers for Medicaid and Medicare Services, which now cover prescription naloxone for individuals on the government insurance coverage programs, states that coverage of over-the-counter naloxone would depend on the insurance coverage program. The centers have actually not provided any main guidance.

Maya Doe-Simkins, a co-director of Remedy Alliance/For The People, which introduced last year to offer affordable-- and sometimes complimentary-- naloxone to neighborhood organizations, said her group will continue to distribute injectable naloxone.

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EXIST DRAWBACKS TO OVER-THE-COUNTER SALES?

One issue is whether individuals who purchase Narcan over the counter will know how to utilize it properly, said Keith Humphreys, a Stanford University addiction professional, though the manufacturer is responsible for clear instructions and online videos on that.

One benefit of having pharmacists involved, he said, is that they can reveal buyers how to utilize it. One crucial thing individuals need to be reminded of: Call an ambulance for the person receiving naloxone after it's been administered.

He likewise stated there are fears that if the drug isn't rewarding as a non-prescription choice, the drugmaker could stop producing it.

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The Associated Press Health and Science Department gets assistance from the Howard Hughes Medical Institute's Science and Educational Media Group. The AP is exclusively responsible for all content.

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