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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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24 Articles

The Daily CallerThe Daily Caller
+3 Reposted by 3 other sources
Right

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.

·Washington, United States
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Krem2 NewsKrem2 News
+8 Reposted by 8 other sources
Center

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.

·Spokane, United States
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wbiw.com broke the news on Tuesday, June 16, 2026.
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