Skip to Main Content
Skip Nav Destination
Narcan nasal spray

AAP expert: FDA approval of OTC naloxone nasal spray is a ‘win’

March 30, 2023

The Food and Drug Administration’s (FDA’s) approval of nonprescription naloxone nasal spray to reverse opioid overdoses is a step in the right direction, according to one AAP expert.

“Still much work to do, but OTC (over-the-counter) availability is a win and will expand access for those who have the financial resources,” said Lucien Gonzalez, M.D., M.S., FAAP, chair of the AAP Committee on Substance Use and Prevention.

The FDA granted approval to Narcan 4 milligram (mg) naloxone hydrochloride nasal spray from Emergent BioSolutions Inc. for over-the-counter use, making it available in drugstores, grocery stores, convenience stores, gas stations and online. The manufacturer said it expects the spray to hit store shelves in late summer. There will be no age restrictions on the purchase or use, according to the FDA.

“Today's approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it's available and help reduce opioid overdose deaths throughout the country,” FDA Commissioner Robert M. Califf, M.D., said in a press release. “We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”

Still, Dr. Gonzalez said, “cost is likely to remain a barrier for many.” He also said questions remain about the impact on prescription coverage and on harm reduction naloxone distribution programs.

Narcan nasal spray was first approved as prescription drug in late 2015. Since that time, more than 44 million doses have been distributed, according to Emergent BioSolutions. Last month, an FDA advisory committee recommended allowing over-the-counter use, leading to Wednesday’s FDA approval.

The FDA said it will be working with partners and manufacturers to help ensure access during the transition period. Generic versions of the 4 mg spray also will be required to switch to over the counter. However, injectable naloxone products and other dosages of the nasal spray will continue to be available with a prescription.

As of October 2022, there had been more than 101,750 fatal drug overdoses in 12 months, largely driven by synthetic opioids like illicit fentanyl, according to the FDA. Adolescents are among those at risk. A recent study found years of life lost due to unintentional overdoses among adolescents ages 10-19 years more than doubled from 2019 to 2020. The years lost among this group in 2020 were higher than for cancer, congenital disorders, heart disease, intentional overdose or chronic lower respiratory disease, the study found.

In a call with partners Thursday, Dr. Califf called drug overdoses “one of the most important public health emergencies that our country faces.” As a cardiologist, he likened naloxone nasal spray to cardiac defibrillators being made widely available.

“A person who would otherwise be dead is given another chance at life,” he said. “There’s no reason to deny people that opportunity whether it’s a cardiac arrest or an opioid overdose.”



Close Modal

or Create an Account

Close Modal
Close Modal