Dec 7, 2022 - Health

FDA fast-tracks review of over-the-counter opioid drug

Illustration of a stopwatch made from a large round prescription pill

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.

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.

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