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First OTC Opioid Overdose Treatment Gains FDA Approval

The Food and Drug Administration on Wednesday approved an over-the-counter version of the opioid overdose reversal drug naloxone, a move that should increase access to the life-saving drug.

Until now, naloxone – sold by drugmaker Emergent BioSolutions under the brand name Narcan – has only been available in the United States as a prescription drug, although many states have created workarounds allowing people to get it directly from pharmacists. It is also often found at community centers, local health departments, and needle exchange programs.

Making the drug available without a prescription could save more lives, said Dr. Scott Hadland, a pediatrician and addiction specialist at MassGeneral Hospital for Children in Boston.

“Narcan can save a life in minutes, which is critical,” he said.

The over-the-counter Narcan, which will be sold as a single dose administered as a nasal spray, is unlikely to be available until late summer, according to the company. FDA officials said once approved, it could be sold in places like convenience stores, grocery stores and even vending machines.

“Today’s approval of over-the-counter naloxone nasal spray will help improve access to naloxone, increase the number of places where it is available, and reduce opioid overdose deaths across the country. “FDA Commissioner Dr. Robert Califf said in a statement.

Wednesday’s approval came just over a month after an FDA advisory panel unanimously recommended that the agency allow Emergent’s drug to be sold without a prescription.

Drug overdoses – the leading cause of accidental deaths in the United States – killed more than 107,000 people in 2021, according to the Centers for Disease Control and Prevention. More than 80,000 of those deaths involved opioids.

Hadland said he’s seen an increase in the number of teens and young adults overdosing.

Most overdose deaths in young people occur at home, he said, usually when there is someone nearby who can respond.

“Yet most young people who overdose never get Narcan and are pulseless by the time EMS arrives,” he said. “Making it available over-the-counter will provide a new avenue of access, especially for young people and families who have not been the focus of our widespread efforts to distribute Narcan across the country,”

The over-the-counter version of naloxone will be packaged in a larger box with pictures and step-by-step instructions to help people administer the drug more easily, the company says.

Dr Michael Barnett, assistant professor of health policy and management at Harvard TH Chan School of Public Health, said that while making naloxone available over the counter is a “huge step”, it is worried about the cost.

“I hope the cost is affordable,” he said.

Emergent declined to share details on the cost of the over-the-counter drugs, but the average price for a two-dose box of prescription-only Narcan is around $130, according to GoodRx, which tracks drug prices.

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