The U.S. Food and Drug Administration (FDA) approved Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter, nonprescription, use. This overdose-reversing drug is the first opioid treatment drug to be sold over-the-counter (OTC).
Drug overdose persists as a major public health issue in the United States, with more than 101,750 reported fatal overdoses occurring in the 12-month period ending in October 2022, primarily driven by synthetic opioids like illicit fentanyl.
The approval of OTC Narcan nasal spray will require a change in the labeling for the currently approved 4 mg generic naloxone nasal spray products that rely on Narcan as their reference listed drug product. Other brands of naloxone and injectable forms will not yet be available over the counter, but they could be soon. Manufacturers of these products will be required to submit a supplement to their applications to effectively switch their products to OTC status.
The application to approve Narcan nasal spray for OTC use was granted priority review status and was the subject of an advisory committee meeting in February 2023, where committee members voted unanimously to recommend it be approved for marketing without a prescription.
In November 2022, the FDA announced its preliminary assessment that certain naloxone products have the potential to be safe and effective for over-the-counter use and encouraged sponsors to submit applications for approval of OTC naloxone products.
>> FDA Press Release
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