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Emergent’s Narcan Gets Nonprescription “Fast Track”

By NAM News Room

Narcan, the nasal-spray form of opioid-reversal drug naloxone, will soon be available over the counter, according to The Wall Street Journal (subscription).

What’s going on: The Food and Drug Administration has fast-tracked an application submitted by Narcan manufacturer Emergent BioSolutions Inc., the company said Tuesday, with an expected approval date of March 29, 2023.

Why it’s important: “The FDA has encouraged pharmaceutical companies to apply for approval for over-the-counter versions of overdose-reversal medications such as Narcan to help confront a swelling overdose crisis from bootleg versions of the powerful opioid fentanyl.” (In 2021, there were over 108,000 drug-overdose deaths in the U.S.) 

  • Last month, the FDA told prescription pharmaceutical companies that once it had enough data to approve an over-the-counter naloxone product, prescription-only versions would be considered “misbranded.”

Expected outcome: Emergent President and CEO Robert Kramer said the transition to nonprescription is to be expected given the opioid crisis.

A post-partisan issue: The move by Emergent comes just eight months after a group of Republican and Democratic legislators sent a letter to major drug manufacturers urging them to apply for over-the-counter status for their naloxone products.

  • Said Rep. Brian Fitzpatrick (R-PA), one of the letter’s signatories, “As the mental health and addiction crisis continues to plague our nation, this is a monumental step forward for the expansion of more accessible treatments for Americans seeking help.”
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