FDA approves third over-the-counter opioid overdose nasal spray

The Food and Drug Administration (FDA) has approved a third over-the-counter version of naloxone nasal spray, Rextovy, a 4 milligram formulation intended for the emergency treatment of opioid overdose. The agency stated that this approval aims to broaden access, encourage market competition which may lead to reduced costs, and provide additional sourcing options for consumers.

Rextovy can be purchased directly by consumers at pharmacies, convenience stores, and online. Naloxone is a critical medication that can reverse the effects of an opioid overdose if administered promptly, typically within minutes of the onset of symptoms. The FDA highlighted that having multiple approved over-the-counter formulations is beneficial for public health.

Mike Davis, acting director of the FDA’s Center for Drug Evaluation and Research, emphasized that empowering individuals without medical training to administer the product can save lives. The product is designed to be safe even if the presence of opioids is uncertain, and its packaging includes clear, picture-based instructions, including the crucial step of calling 911.

While the number of overdose deaths has seen a significant decrease since the first FDA approval of an OTC naloxone nasal spray in 2023, drug overdose remains a critical public health challenge in the U.S., largely fueled by synthetic opioids like fentanyl. Federal figures indicate a substantial drop in overdose deaths, from 111,451 in the 12 months ending August 2023 to 68,632 in the 12 months ending December 2025.