The US Food and Drug Administration (FDA) has approved over-the-counter sales of the overdose reversal agent Narcan (naloxone, Emergent BioSolutions). Greater access to the drug should mean more lives saved. However, it's unclear how much the nasal spray will cost and whether pharmacies will stock the product openly on shelves.
Currently, major pharmacy chains such as CVS and Walgreens make naloxone available without prescription, but consumers have to ask a pharmacist to dispense the drug.
"The major question is what is it going to cost," said Brian Hurley, MD, MBA, president-elect of the American Society of Addiction Medicine. "In order for people to access it they have to be able to afford it," he told Medscape.
"We won’t accomplish much if people can't afford to buy Narcan," said Chuck Ingoglia, president and CEO of the National Council for Mental Wellbeing, in a statement. Still, he applauded the FDA.
"No single approach will end overdose deaths but making Narcan easy to obtain and widely available likely will save countless lives annually," he said.
"The timeline for availability and price of this OTC product is determined by the manufacturer," said the FDA in a statement. Commissioner Robert M. Califf, MD, called for the drug's manufacturer to "make accessibility to the product a priority by making it available as soon as possible and at an affordable price."
Emergent BioSolutions did not comment on cost. It said in a statement that the spray "will be available on US shelves and at online retailers by the late summer," after it has adapted Narcan for direct-to-consumer use, including more consumer-oriented packaging.
Naloxone’s cost varies, depending on geographic location and whether it is generic. According to GoodRX, a box containing two doses of generic naloxone costs $31 to $100, depending on location and coupon availability.
A two-dose box of Narcan costs $135-$140. Emergent reported a 14% decline in naloxone sales in 2022 — to $373.7 million — blaming it in part on the introduction of generic formulations.
Hurley said he expects those who purchase Narcan at a drug store will primarily already be shopping there. It may or may not be those who most often experience overdose, such as people leaving incarceration or experiencing homelessness, he said.
Having Narcan available over-the-counter "is an important supplement but it doesn’t replace the existing array of naloxone distribution programs," Hurley said.
The FDA has encouraged naloxone manufacturers to seek OTC approval for the medication since at least 2019, when it designed a model label for a theoretical OTC product.
In November, the agency said it had determined that some naloxone products had the potential to be safe and effective for over-the-counter use and again urged drugmakers to seek such an approval.
Emergent BioSolutions was the first to pursue OTC approval, but another manufacturer — the nonprofit Harm Reduction Therapeutics — is awaiting approval of its application to sell its spray directly to consumers.
Scott Gottlieb, MD, who was the FDA Commissioner from 2017-2019, said in a tweet that more work needed to be done.
"This regulatory move should be followed by a strong push by elected officials to support wider deployment of Narcan, getting more doses into the hands of at risk households and front line workers," he tweeted.
Ingoglia said that "Narcan represents a second chance. By giving people a second chance, we also give them an opportunity to enter treatment if they so choose. You can't recover if you're dead, and we shouldn't turn our backs on those who may choose a pathway to recovery that includes treatment."
Alicia Ault is a Saint Petersburg, Florida-based freelance journalist whose work has appeared in publications including JAMA and Smithsonian.com. You can find her on Twitter @aliciaault.
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Cite this: FDA Approves OTC Naloxone, but Will Cost Be a Barrier? - Medscape - Mar 29, 2023.