The U.S. Food and Drug Administration has approved another over-the-counter intranasal naloxone product, Rextovy, a 4 mg naloxone hydrochloride nasal spray for the emergency treatment of opioid overdose. Consumers can now purchase this product without a prescription at pharmacies, convenience stores, and online. The approval is part of the broader Great American Recovery Initiative.
“Reducing opioid overdose deaths is a top priority for FDA,” said Dr. Mike Davis, Acting Director of the Center for Drug Evaluation and Research. “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 the standard treatment for reversing opioid overdoses. Rextovy contains the same active ingredient as other naloxone nasal sprays now available without a prescription. Multiple approved OTC formulations are now on the market, which the FDA expects will increase competition.
Overdose deaths have dropped dramatically since the first OTC naloxone nasal spray was approved in 2023 — from 111,451 deaths in the 12 months ending August 2023 to 68,632 in the 12 months ending December 2025 — though synthetic opioids like illicit fentanyl continue to drive the crisis.
“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 Dr. Karen Murry, Director of the Office of Nonprescription Drug Products in CDER.
Common side effects associated with Rextovy include shaking, sweating, nausea, and agitation as the person regains consciousness. The product is safe to administer even when the presence of opioids is uncertain. The packaging includes pictorial instructions with five steps and directs users to call 911 after the first dose.
The FDA granted the nonprescription approval to Amphastar Pharmaceuticals, Inc.
Source: FDA Press Release
