Illustration: Annelise Capossela/Axios
A nasal spray for reversing opioid overdoses could become available over-the-counter as early as next March after the Food and Drug Administration gave it priority review.
Why it matters: Advocacy groups, medical associations and federal agencies have said expanding the availability of naloxone is critical to addressing the addiction epidemic that killed more than 100,000 Americans last year.
- Making naloxone easier to obtain could also reduce the stigma of asking for a prescription, per a 2021 report from Integrated Pharmacy Research and Practice.
Driving the news: The FDA fast-tracked the application from Emergent BioSolutions — the maker of Narcan — for a non-prescription version of naloxone, the company announced on Tuesday.
- If approved, the spray would become the first naloxone product on the market that wouldn’t require a doctor's sign-off, though most states already have access laws to bypass the requirement.
Yes, but: At roughly $160, the cost can be prohibitive and insurers vary in their coverage of naloxone.
- Community health organizations and public health departments have absorbed some of the cost to distribute the drug free-of-cost.
- Other free vending machines have popped up across the country in New York City and Los Angeles County to dispense doses.
Catch up quick: The FDA approved a high-dose nasal spray in May 2021 and in mid-November, began pushing drugmakers to submit over-the-counter naloxone applications.