First OTC naloxone nasal spray approved by FDA
On March 29, the U.S. Food and Drug Administration approved Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray, for over-the-counter (OTC), nonprescription use. This is the first naloxone product approved nationwide for use without a prescription.

Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment.

Manufacturer Emergent BioSolutions will determine the timeline for the availability and price of the OTC product. In a press release, the company shared it hopes to make Narcan available in stores by late summer.

“The FDA remains committed to addressing the evolving complexities of the overdose crisis. As part of this work, the agency has used its regulatory authority to facilitate greater access to naloxone by encouraging the development of and approving an over-the-counter naloxone product to address the dire public health need,” said FDA Commissioner Robert M. Califf, MD. 

Hoosiers’ access to Narcan in recent years has been wide-reaching compared to many other states.

Since 2015, Indiana has had a standing order allowing any adult in the state to purchase naloxone without a prescription from any of 780 registered pharmacies (as of January 2023). There are also 19 naloxone vending machines statewide and more than 200 NaloxBoxes statewide, among other resources.

IDOH also provides grants to help local health departments distribute naloxone in their communities. 

In the past year, 52 health departments provided more than 62,000 doses of naloxone, according to WFYI.

Additional resources:

Indiana Department of Health Overdose Prevention: Naloxone

Indiana Drug Overdose Dashboard

Indiana Naloxone Administration Heat Map

Naloxone distribution registry

Naloxone Resource Guide for Local Health Departments


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