The U.S. FDA has approved Rextovy, a 4 mg naloxone hydrochloride nasal spray, as an additional over-the-counter (OTC) option for reversing opioid overdose, broadening public access to a life-saving medication.
Naloxone is the standard emergency treatment for opioid overdose and rapidly reverses its effects, allowing bystanders to intervene even without medical training.
Expanding Consumer Access
With this approval, consumers can now purchase Rextovy without a prescription in pharmacies, convenience stores, and online marketplaces, increasing availability in everyday settings where overdoses may occur.
The FDA noted that expanding OTC naloxone options supports national efforts to address the ongoing addiction and overdose crisis, including initiatives focused on prevention, treatment, and long-term recovery.
FDA Leadership Highlights Public Health Priority
"Reducing opioid overdose deaths is a top priority for the FDA," said Mike Davis, Acting Director of the Center for Drug Evaluation and Research. He emphasized that broader access to OTC naloxone empowers individuals to take immediate action during an overdose, which has been shown to save lives.
Karen Murry, M.D., Director of the Office of Nonprescription Drug Products in CDER, added that ensuring widely available nonprescription naloxone remains a key focus for the agency, and encouraged manufacturers interested in OTC pathways to engage with the FDA early in development.
Continued Need Despite Declining Overdose Deaths
Although overdose deaths have decreased significantly since the first OTC naloxone approval in 2023, opioid-related fatalities—particularly those involving illicit fentanyl—remain a major public health challenge. Reported 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.
Product Information and Safety
Rextovy contains the same active ingredient used in other naloxone nasal sprays and includes clear pictorial instructions for use, including calling 911 after administering the first dose.
Some individuals may experience symptoms such as shaking, sweating, nausea, or anger when regaining consciousness after overdose reversal, but the product is safe to use even when opioid exposure is uncertain.
The FDA granted the nonprescription approval to Amphastar Pharmaceuticals, Inc.
Source: FDA
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