FDA Approves OTC Naloxone Consistent with Longstanding ASA Recommendations

On March 29, the Food and Drug Administration (FDA) approved Narcan nasal spray for nonprescription use, the first naloxone product approved for use without a prescription. ASA has long supported equitable community access to naloxone - a safe, life-saving medication that can rapidly reverse an opioid overdose and significantly reduce the incidence of opioid overdose fatalities - to all patients across the United States as a nonprescription treatment.

Last month, ASA member Bonnie Milas, MD, testified before the FDA Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee meeting in support of over the counter (OTC) availability and increased community access to naloxone nasal spray.

In formal communications to the FDA, ASA consistently conveyed support for OTC naloxone, and reaffirmed naloxone is a medication that is safe for all members of the public to administer. 

ASA thanks the FDA for expanding access to this lifesaving medication.

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