FDA approves third OTC naloxone nasal spray

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1–2 minutes

Summary

FDA approved Rextovy, a third over-the-counter naloxone nasal spray for emergency opioid overdose treatment.

Why this matters

The approval adds another nonprescription naloxone option that consumers can buy directly, potentially expanding access. Federal regulators said more products on the market could increase availability and lower costs.

The Food and Drug Administration on Tuesday approved Rextovy, a 4-milligram naloxone nasal spray for emergency treatment of opioid overdose, making it the third naloxone spray cleared for over-the-counter sale.

The agency said consumers may buy Rextovy directly in pharmacies, convenience stores, and online.

The Food and Drug Administration said multiple approved over-the-counter formulations could expand access and market availability, encourage competition that may reduce costs, and provide alternative sourcing options.

The prescription version of Rextovy sells for about $44 to $60 per box, but over-the-counter pricing was not immediately available.

“The approval helps broaden access and offers an additional option for consumers. Empowering people without medical training to take immediate action with these products has been proven to save lives,” Mike Davis, acting director of the Food and Drug Administration’s Center for Drug Evaluation and Research, said in a statement.

The agency said the product is safe to use even when it is unclear whether opioids are present in a person’s system. The packaging includes illustrated directions with five steps, including calling 911 after the first dose.

The Food and Drug Administration said overdose deaths have declined since it first approved an over-the-counter naloxone nasal spray in 2023, but drug overdoses remain a major public health issue in the United States, driven primarily by synthetic opioids such as illicit fentanyl.

Federal figures show 111,451 overdose deaths were reported in the 12-month period ending in August 2023, compared with 68,632 in the 12-month period ending in December 2025.

Narcan, the first naloxone nasal spray, was approved in 2015 to treat known or suspected opioid overdoses in people of all ages, including newborns.

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