Dec 7, 2022 - Health

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

Sabrina Moreno

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.

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.

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

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