FDA approves opioid antidote for over-the-counter sales

A life-saving medication has been approved for over-the-counter sales.
Published: Mar. 29, 2023 at 5:26 PM EDT
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MICHIGAN (WNEM) - A life-saving medication has been approved for over-the-counter sales.

On Wednesday, March 27, the FDA announced that the opioid overdose antidote Narcan has been approved for over-the-counter sales, calling the need “dire.”

Unintentional drug overdose is a leading cause of preventable death in the U.S. and advocates hope this increased access will save lives.

“This is a good day for anyone in harm reduction or anyone who knows a person who uses drugs,” Prevention Point Philadelphia’s Director of Prevention Services Nicole Sage said.

Pharmacy and grocery store shelves will soon stock the overdose treatment drug naloxone. The FDA approved over-the-counter sales under the brand name Narcan, a nasal spray in 4-milligram doses. Given in time, it blocks the brain from the effects of street drugs like heroin and fentanyl and prescription opioids like oxycodone.

“If it’s in the store in the aisle, right next to ibuprofen, it really also helps to reduce stigma,” Sage said.

All 50 states have naloxone access laws and most allow pharmacists to dispense to anyone who asks, but not every pharmacy carries it, and customers have to use an insurance co-pay or pay full retail price. The FDA is encouraging the manufacturer to make Narcan affordable, as the country battles an overdose epidemic.

CDC data reveals more than 100,000 reported fatal overdoses in the 12-month period ending in October, the majority involving opioids. Previous studies suggest bystanders who carried naloxone helped save lives. It’s also fairly simple to administer.

“You put the person on their back and you insert this top party into their nostril and it’s like a plunger, so you put your thumb on the red part and you push in,” UCSB Program Director Angie Bryan said.

The manufacturer expects Narcan will be available over the counter by late summer.

Related: Vending machine dispenses free Narcan to those in need

Other naloxone brands and injectable forms will have to file applications with the FDA to make their products available over the counter. According to state data, from January to September 2022, more than 1,900 Michigan residents died from an overdose. For more information on Michigan’s overdose data, head to the Wednesday hotlinks section.

Related: Local health department opens vending machine supplied with NARCAN

Several facilities are also installing free Narcan vending machines. Currently, there are free Narcan vending machines inside the Saginaw County Health Department, Tuscola County Health Department, and the Mass Transportation Authority Transit Center in downtown Flint thanks to the Genesee Community Health Center and the Genesee Health System.

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