Overview
- The FDA approved an additional OTC naloxone nasal spray on Tuesday, expanding the nonprescription options for emergency opioid overdose reversal.
- The product approved is Rextovy, a 4-milligram intranasal naloxone hydrochloride spray that becomes the third naloxone nasal spray cleared for OTC sale.
- FDA officials say naloxone is safe to use even when it is unclear whether opioids are present and they instruct bystanders to call 911 after giving the first dose.
- The agency framed multiple OTC approvals as a way to broaden sourcing and foster price competition, but the OTC retail price for Rextovy has not yet been announced and the prescription version has sold for about $44–$60 per box.
- Public-health data show overdose deaths fell from roughly 110,000 in 2022 to about 69,000 in 2025 and experts credit changes in the drug supply, expanded treatment and wider naloxone access while warning that synthetic opioids such as fentanyl remain a major risk.