FDA approves third over-the-counter opioid overdose nasal spray
The 4-mg nasal spray joins other nonprescription options as overdose deaths fell to about 69,000 in 2025, CDC data show.
- On Tuesday, the FDA approved Rextovy, a 4-mg intranasal naloxone spray, for over-the-counter use, joining other nonprescription opioid overdose treatments to expand access to life-saving emergency tools.
- Regulatory efforts to normalize nonprescription access began in 2023, when the FDA approved the first OTC naloxone product, signaling the agency's commitment to ensuring overdose reversal tools remain widely available.
- People should call 911 after the first dose, though naloxone is safe even when it's unclear if opioids are present. "Don't hesitate to administer naloxone in an emergency even if you're not sure," Marta Sokolowska, deputy center director for substance use and behavioral health at the FDA, said.
- Karen Murry, MD, director of the Office of Nonprescription Drug Products, said the approval fosters market competition and could reduce costs, as the FDA encourages other manufacturers to pursue nonprescription naloxone approvals.
- Overdose deaths reached 110,000 in 2022 but declined to about 69,000 in 2025, according to CDC data; experts attribute this downward trend to multiple factors, including broader naloxone availability and improved access to opioid addiction treatment.
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FDA Approves 4 Mg Rextovy as Third Over-the-Counter Naloxone Product
The Food and Drug Administration has granted over-the-counter (OTC) approval to Rextovy, a 4 mg naloxone nasal spray product manufactured by Amphastar Pharmaceuticals. The agency announced its decision June 16, nearly three years after its last OTC naloxone approval. Rextovy is the third naloxone product to switch from prescription to OTC, a move that will help incrementally lower the retail price of a medication that should be available to the …
Trump FDA Tackles Opioid Crisis With New Medication Approval
The Food and Drug Administration approved a new over-the-counter naloxone nasal spray on Tuesday in an effort to combat the nation's opioid overdose crisis.
The FDA approves an additional over-the-counter naloxone nasal spray to combat opioid overdoses
Consumers will be able to purchase Rextovy without a prescription at locations including pharmacies, convenience stores and online retailers.
FDA approves third over-the-counter nasal spray to treat opioid drug overdoses
The FDA said the number of overdose deaths has dramatically decreased since it first approved Narcan in 2023, but drug overdose persists as a major public health issue in the U.S., primarily driven by synthetic opioids like illicit fentanyl.

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