science
FDA Approves Third Over-the-Counter Naloxone Nasal Spray
The agency cleared Rextovy, a 4-milligram naloxone nasal spray, for sale without a prescription. The product joins two earlier over-the-counter formulations already on the market.
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The Food and Drug Administration approved Rextovy, a 4 milligram naloxone nasal spray, on Tuesday for emergency treatment of opioid overdose. Consumers can purchase the product directly in pharmacies, convenience stores, and online. Rextovy is the third naloxone nasal spray cleared for over-the-counter use.
The first such approval occurred in 2023. Mike Davis, acting director of the FDA’s Center for Drug Evaluation and Research, said the approval helps broaden access and offers an additional option for consumers. He added that empowering people without medical training to take immediate action with these products has been proven to save lives.
The product is safe to use even when it is uncertain whether opioids are present. Its packaging includes picture directions with five clear steps, including calling 911 after the first dose. The prescription version of naloxone nasal spray sells between $44 and $60 per box.
Pricing for the over-the-counter version of Rextovy was not immediately available. The first naloxone nasal spray, Narcan, was approved in 2015 to treat known or suspected opioid overdoses for people of all ages, including newborns. Federal figures show overdose deaths fell from 111,451 in the 12-month period ending August 2023 to 68,632 in the 12-month period ending December 2025.
U.S. are primarily driven by synthetic opioids like illicit fentanyl.
