The U.S. Food and Drug Administration has approved Rextovy, an over-the-counter naloxone nasal spray used to treat opioid overdoses.
Consumers can directly purchase the 4-milligram naloxone hydrochloride nasal spray without a prescription in places like pharmacies, convenience stores and online, the FDA said in a Tuesday news release.
Naloxone is a medication that rapidly reverses the effects of an opioid overdose. The FDA approved Narcan, the first over-the-counter naloxone nasal spray, in March 2023. It had been approved as a prescription drug since 2015.
Rextovy has the same active ingredient as other naloxone nasal sprays. The availability of multiple approved formulations expands access and market availability, encourages competition that may reduce cost and offers alternative pricing solutions, the FDA said.
C-store and gas station parking lots and bathrooms have been among the common locations of opioid overdoses.
In July 2024, an initiative from the Cook County Sheriff’s Office and other community advocates made naloxone available at gas stations in Chicago neighborhoods that had high numbers of reported overdoses.
Overdose deaths have dramatically decreased since the first FDA approval of Narcan, the FDA said, but drug overdoses persist. In the 12-month period ending in August 2023, 111,451 overdose deaths were reported, while in the 12-month period ending December 2025, 68,632 overdose deaths were reported, the agency said.
“Immediate access to naloxone nasal sprays is essential when a person is experiencing an overdose, and FDA remains committed to ensuring nonprescription options are widely available,” said Karen Murry, director of the Office of Nonprescription Drug Products in the Center for Drug Evaluation and Research. “We are proud of the dedicated work our review divisions put into making this approval possible, and we encourage any manufacturer seeking to market a nonprescription naloxone product to contact the agency to initiate a conversation.”
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