WASHINGTON (dpa-AFX) - The U.S. Food and Drug Administration has approved another over-the-counter (OTC) intranasal naloxone product for the emergency treatment of opioid overdose. Consumers may directly purchase Rextovy, a 4 milligram naloxone hydrochloride nasal spray, without a prescription in places such as pharmacies, convenience stores, and online.
This action aligns with President Trump's Great American Recovery Initiative, a federal effort to address the country's addiction and substance use disorder crisis and coordinate the government's approach to prevention, treatment, and long-term recovery.
Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for such symptoms. Rextovy is an additional life-saving medication approved by the FDA to reverse an opioid overdose to be sold directly to consumers and contains 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 sourcing options, FDA said.
The number of overdose deaths has dramatically decreased since the first FDA approval of an OTC naloxone nasal spray in 2023, but drug overdose persists as a major public health issue in the U.S., primarily driven by synthetic opioids like illicit fentanyl. In the 12-month period ending in August 2023, 111,451 overdose deaths were reported; in the 12-month period ending in December 2025, 68,632 overdose deaths were reported.
'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 CDER.
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