FDA Approves Over-the-Counter Naloxone Nasal Spray

March 29, 2023

The FDA has approved the first over-the-counter (OTC) Naloxone nasal spray, a move federal officials say will increase the availability of the lifesaving drug.

The FDA authorization of the Narcan nasal spray means the product can be sold directly to consumers in drug, grocery, and convenience stores, gas stations, and online without a prescription, FDA officials said. It would also be the first opioid treatment drug to be available over the counter, according to media reports.

“Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available, and help reduce opioid overdose deaths throughout the country,” FDA Commissioner Robert M. Califf, MD, said on Wednesday.

Here’s what you need to know:

• About:  The medication from Emergent BioSolutions rapidly reverses the effects of opioid overdose.
  • In response to the FDA order, other similar Naloxone nasal spray products will be required to submit a supplement to their applications to effectively switch their products to OTC status.
• Overall challenge:  More than 101,750 fatal overdoses were reported in the 12-month period ending October 2022. Fentanyl and other synthetic opioids were drivers of the trend.
• Improving availability:  In recent years, naloxone distribution has increased beyond health care professionals to include first responders, family members, and other people who may witness and be able to respond to an opioid overdose.
• Pennsylvania order:  In Pennsylvania, state residents already can purchase or use their insurance to obtain naloxone at local pharmacies without a prescription due to the Department of Health’s standing order. 
• Quotable:  “We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.” 

HAP continues to support policies and legislation that address the state’s opioid crisis and improve our behavioral health care system. Learn more about our behavioral health advocacy.

Additional information about the FDA approval is available online.