UNITED STATES

FDA approves over-the-counter Narcan, original naloxone still available

Mar 29, 2023, 7:50 AM | Updated: Jan 9, 2024, 12:23 pm

The U.S. Food and Drug Administration on Wednesday approved selling naloxone without a prescription...

FILE: In this photo illustration, a Narcan nasal overdose kit, given out free by the city of New York, is displayed. (Spencer Platt/Getty Images)

(Spencer Platt/Getty Images)

The U.S. Food and Drug Administration on Wednesday approved selling Narcan without a prescription, putting 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.

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.

The Utah Angle:  Could legalizing psychoactive mushrooms cut down on opioid epidemic?

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 offering naloxone over-the-counter improve access?

It clears the way for Narcan to be made available in places without pharmacies — convenience stores, supermarkets and online retailers, for instance.

Jose Benitez, the lead executive officer at Prevention Point Philadelphia, an organization that tries to reduce risk for people who use drugs with services including handing out free naloxone, said it could help a lot for people who don’t seek services — or who live in places where they’re not available.

Now, he said, some people are concerned about getting naloxone at pharmacies because their insurers will know they’re getting it.

“Putting it out of the shelves is going to allows people just to pick it up, not have stigma attached to it and readily access this life-saving drug,” he said.

But it remains to be seen how many stores will carry it and what the prices will be. The U.S. Centers for Medicaid and Medicare Services, which now cover prescription naloxone for people on the government insurance programs, says that coverage of over-the-counter naloxone would depend on the insurance program. The centers have not given any official guidance.

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

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.
___
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

We want to hear from you.

Have a story idea or tip? Send it to the KSL NewsRadio team here.

United States

FILE - The U.S Supreme Court is photographed, Jan. 3, 2024, in Washington.  (AP Photo/Mariam Zuhaib...

John Fritze, CNN

Supreme Court keeps Trump on Colorado ballot, rejecting 14th Amendment push

The Supreme Court ruled Monday that former President Donald Trump should appear on the ballot in Colorado in a decision that follows months of debate.

7 hours ago

FILE: Seen from an aerial view, people pass through razor wire after crossing the U.S.-Mexico borde...

ACACIA CORONADO

Judge blocks Texas law allowing police power to arrest illegal migrants

The ruling is a victory for the Justice Department. It argued that the law signed by Republican Gov. Greg Abbott last year was unconstitutional.

4 days ago

president biden shown, he and former president trump are visiting the border in texas...

SEUNG MIN KIM, JILL COLVIN and COLLEEN LONG Associated Press

Biden and Trump touch down in Texas, highlighting immigration as a major election issue

President Joe Biden and former President Donald Trump arrived Thursday in Texas, for dueling trips to the U.S.-Mexico border in a sign of how central immigration has become to the 2024 election

4 days ago

texas wildfires...

Associated Press

Wildfire grows into one of largest in Texas history as flames menace multiple small towns

Known as the Smokehouse Creek Fire, the largest blaze expanded to more than 1,300 square miles and jumped into parts of neighboring Oklahoma.

5 days ago

execution chamber in idaho prison...

Associated Press

Idaho halts execution by lethal injection after 8 failed attempts to insert IV line

Thomas Eugene Creech Creech, one of the longest-serving death row inmates in the U.S., was wheeled into the execution chamber at the Idaho Maximum Security Institution on a gurney at 10 a.m.

5 days ago

DEARBORN, MICHIGAN - FEBRUARY 27: A sign for Republican presidential candidate former President Don...

Marshall Cohen, CNN

Illinois judge removes Trump from ballot, cites ‘insurrectionist ban’

Wednesday’s unexpected decision comes as a similar challenge from Colorado is pending before the U.S. Supreme Court.

5 days ago

Sponsored Articles

Mother and cute toddler child in a little fancy wooden cottage, reading a book, drinking tea and en...

Visit Bear Lake

How to find the best winter lodging in Bear Lake, Utah

Winter lodging in Bear Lake can be more limited than in the summer, but with some careful planning you can easily book your next winter trip.

Happy family in winter clothing at the ski resort, winter time, watching at mountains in front of t...

Visit Bear Lake

Ski more for less: Affordable ski resorts near Bear Lake, Utah

Plan your perfect ski getaway in Bear Lake this winter, with pristine slopes, affordable tickets, and breathtaking scenery.

front of the Butch Cassidy museum with a man in a cowboy hat standing in the doorway...

Bear Lake Convention and Visitors Bureau

Looking Back: The History of Bear Lake

The history of Bear Lake is full of fascinating stories. At over 250,000 years old, the lake has seen generations of people visit its shores.

silhouette of a family looking over a lake with a bird in the top corner flying...

Bear Lake Convention and Visitors Bureau

8 Fun Activities To Do in Bear Lake Without Getting in the Water

Bear Lake offers plenty of activities for the whole family to enjoy without having to get in the water. Catch 8 of our favorite activities.

Wellsville Mountains in the spring with a pond in the foreground...

Wasatch Property Management

Advantages of Renting Over Owning a Home

Renting allows you to enjoy luxury amenities and low maintenance without the long-term commitment and responsibilities of owning a home.

Clouds over a red rock vista in Hurricane, Utah...

Wasatch Property Management

Why Southern Utah is a Retirement Paradise

Retirement in southern Utah offers plenty of cultural and recreational opportunities. Find out all that this region has to offer.

FDA approves over-the-counter Narcan, original naloxone still available