UPDATE: FDA Authorizes First Naloxone Product as Over-the-Counter Medicine

March 30, 2023


Elizabeth (Izzy) Montgomery, MPA
Policy Analyst


ACHI Communications

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(Original post published January 26, 2023)

On Wednesday (March 29), the U.S. Food and Drug Administration (FDA) approved the first naloxone product for over-the-counter, non-prescription use.

Naloxone — distributed under the brand name Narcan — is a lifesaving drug that can reverse the effects of an opioid overdose. With national rates of opioid overdoses increasing in recent years, both federal and state officials are working toward making naloxone more readily available to individuals at risk of opioid overdose.

In the approval, the FDA authorized over-the-counter dispensing of Narcan in a 4 mg nasal spray. The agency emphasized that other formulations and dosages of naloxone will continue to be available by prescription only, and that it will coordinate with stakeholders to continue providing access to naloxone products during Narcan’s transition from prescription to over-the-counter status.

The opioid epidemic continues to be a major public health issue in Arkansas. Overdose deaths grew in Arkansas from 388 in 2019 to 637 in 2021, an increase of 64%.

In May 2022, ACHI and the Arkansas Department of Human Services launched a program called NaloxHome. Funded through the federal Substance Abuse and Mental Health Services Administration, the program provides free naloxone to hospitals to dispense at discharge from emergency departments to patients or caregivers of patients who have experienced an overdose or are at risk of an overdose. Since the program’s inception, 38 hospitals across Arkansas have enrolled.

See also our analysis of naloxone and opioid prescriptions in Arkansas.

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