FDA Approves New OTC Naloxone Nasal Spray For Opioid Overdose

The U.S. Food and Drug Administration approved Rextovy, a new over-the-counter intranasal naloxone spray (4 mg dose), making it the third nonprescription option available in the U.S. for reversing opioid overdoses.

Naloxone is the standard treatment for reversing opioid overdoses, including those involving illicit fentanyl. While national overdose deaths have declined — from more than 111,000 in 2023 to approximately 68,000 in late 2025 — opioid overdose remains a major public health challenge, especially due to synthetic opioids like fentanyl.

Health care providers and hospitals play a critical role in continuing to expand access to naloxone, educate patients and families, and support community distribution efforts.