ISSUE1762
- Jean-Marie Pflomm, Pharm.D., Editor in Chief has disclosed no relevant financial relationships.
- Michael Viscusi, Pharm.D., Associate Editor has disclosed no relevant financial relationships.
- Discuss the availability of naloxone products for treatment of opioid overdose.
The FDA has approved the over-the-counter (OTC) sale of Rextovy (Amphastar), a nasal spray formulation of the opioid antagonist naloxone, for emergency treatment of opioid overdose.1 Other naloxone nasal sprays (Narcan, and generics; RiVive) are also available OTC (see Table 1).2,3
Rextovy was approved in 2023 as a prescription product. It was approved for OTC sale based on data demonstrating that it is safe and effective for use as directed in the proposed labeling and that consumers can use it properly without the supervision of a healthcare professional.4
Naloxone is the drug of choice for reversal of opioid overdose. According to the CDC, persons (and their close contacts) who take opioids illicitly, in high doses, or concurrently with benzodiazepines should carry naloxone.5 Every state in the US now has a naloxone access law; in most states, these laws grant both civil and criminal immunity to laypersons who administer the drug.6
Rextovy is available in packages containing two single-use nasal spray devices, each of which delivers 4 mg of naloxone. The recommended initial dose is one spray in one nostril; additional doses can be administered in alternating nostrils every 2-3 minutes as needed until emergency medical personnel arrive.
- FDA News Release. FDA broadens access to over-the-counter naloxone nasal spray for opioid overdose. June 16, 2026. Available at: https://bit.ly/43Nz0KB. Accessed August 11, 2026.
- In brief: Over-the-counter Narcan nasal spray. Med Lett Drugs Ther 2023; 65:72.
- In brief: A new OTC naloxone nasal spray (RiVive). Med Lett Drugs Ther 2024; 66:47.
- FDA. Prescription-to-nonprescription (Rx-to-OTC) switches. May 21, 2026. Available at: https://bit.ly/43Tndu7. Accessed August 11, 2026.
- CDC. Lifesaving naloxone. June 11, 2025. Available at: https://bit.ly/3QfTetm. Accessed August 11, 2026.
- Legislative Analysis and Public Policy Association. Overdose reversal agent access: summary of state laws. January 2025. Available at: https://bit.ly/4fVXruI. Accessed August 11, 2026.
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