Emergent BioSolutions Gains Priority Review for OTC Naloxone Application

December 7, 2022

The FDA has granted a priority review to Emergent BioSolutions’ supplemental New Drug Application (sNDA) for its over-the-counter Narcan (naloxone HCI) nasal spray for emergency treatment of opioid overdose.

The sNDA is supported by more than five years of postmarket data regarding Narcan’s efficacy and safety, and data from human factors studies of the nasal spray’s user interface.

If the application receives FDA approval, it would be the first naloxone nasal spray available in the U.S. in over-the-counter form.

The FDA’s decision date on the sNDA is March 29, 2023.

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