FDA Approves Second Over-the-Counter Naloxone Nasal Spray

The Food and Drug Administration approved Rextovy, a naloxone nasal spray containing 4 milligrams of naloxone hydrochloride, for over-the-counter distribution to reverse opioid overdoses.

Rextovy becomes the second naloxone nasal spray the FDA has cleared for nonprescription use. Narcan, a similar product, received over-the-counter approval in 2023.

Naloxone blocks opioid receptors in the brain and can rapidly restore normal breathing in people experiencing an overdose. Emergency responders and harm reduction organizations have used the drug for years in clinical and community settings.

The move allows consumers to purchase Rextovy from pharmacies and retailers without a prescription, mirroring the regulatory pathway the FDA established for Narcan. Both products deliver naloxone through nasal spray, which medical professionals and lay users can administer quickly during an overdose emergency.

The opioid epidemic has driven recent FDA decisions to expand naloxone access. More than 100,000 Americans died from opioid-involved overdoses in 2021 and 2022, according to federal data. Public health officials have cited widespread availability of naloxone as a tool to reduce overdose deaths.

The approval of multiple over-the-counter naloxone formulations reflects federal efforts to remove barriers between people at risk of overdose and the medication. Prior to recent regulatory changes, naloxone typically required a prescription or came through standing order programs in limited jurisdictions.

Retailers and pharmacies will determine their own stocking and pricing decisions for Rextovy. Narcan's over-the-counter approval led several major pharmacy chains to sell the product, though prices and availability vary by location.