Amphastar Pharmaceuticals Gets FDA Approval for Over-The-Counter Nasal Spray for Opioid Overdose

By Kelly Cloonan

Amphastar Pharmaceuticals got approval from the Food and Drug Administration for an over-the-counter nasal spray to treat opioid overdose.

The FDA said Tuesday the approval of Amphastar's Rextovy aims to expand access to naloxone nasal sprays, offer an additional option for consumers and encourage competition that may reduce cost. It also aligns with the federal government's efforts to address addiction and substance use disorders in the U.S., the FDA said.

Consumers will be able to directly purchase Rextovy without a prescription at pharmacies, convenience stores and online, the FDA said. Rextovy contains the same active ingredient as other naloxone nasal sprays.

The FDA said the number of overdose deaths has decreased since its first approval of an over-the-counter naloxone nasal spray in 2023, however drug overdose remains a major public health issue in the U.S.

In the year ended December 2025, 68,632 overdose deaths were reported, compared with 111,451 overdose deaths reported in the year ended in August 2023, the FDA said.

Write to Kelly Cloonan at kelly.cloonan@wsj.com

(END) Dow Jones Newswires

June 16, 2026 13:05 ET (17:05 GMT)