The U.S. Food and Drug Administration (FDA) today approved another over-the-counter (OTC) intranasal naloxone product, Rextovy, a 4 milligram (mg) naloxone hydrochloride nasal spray for the emergency treatment of opioid overdose. Consumers may directly purchase this product 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 U.S.’ addiction and substance use disorder crisis and coordinate the government's approach to prevention, treatment, and long-term recovery.
“Reducing opioid overdose deaths is a top priority for FDA,” said Mike Davis M.D., Ph.D., Acting Director of the Center for Drug Evaluation and Research (CDER). “Today’s approval of an additional over-the-counter naloxone nasal spray 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.”
Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose. 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.
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.1
“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, M.D., Director of the Office of Nonprescription Drug Products in CDER. “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.”
When using Rextovy, some people may experience symptoms when they regain consciousness following overdose reversal, such as shaking, sweating, nausea, or feeling angry. The product is safe to use even when it is uncertain whether opioids are present in the person’s system. The product’s packaging includes pictorial directions with five clear steps, including calling 911 after giving the first dose.
The FDA granted the nonprescription approval to Amphastar Pharmaceuticals, Inc.
1 Products - Vital Statistics Rapid Release - Provisional Drug Overdose Data
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