FDA Approves New Narcan Packaging, Aiming to Boost Carry Rates

The United States Food and Drug Administration (US FDA) has approved Emergent BioSolutions’ supplemental New Drug Application (sNDA) for over-the-counter (OTC) naloxone HCl Nasal Spray 4 mg (Narcan) to be packaged in a new carrying case to improve ease of transport and usability.1

The new case includes 2 blister packs, each enclosed with Quick Start Guide, and is designed to be compact, discreet and durable, with the goal making naloxone more readily carried and available. The new design aims to reduce the stigma often associated with carrying naloxone and to increase its rates of carry and chances of its use in emergencies.

“Every second counts in an opioid emergency, and our mission at Emergent is to ensure that life-saving tools like OTC NARCAN® Nasal Spray are readily available, easily accessible and are second nature to carry,” said Paul Williams, senior vice president, head of products business, global government and public affairs at Emergent. “In response to the ongoing opioid overdose epidemic, we believe this new carrying case is an additional option for our customers and consumers to acquire, while encouraging preparedness and expanding accessibility to help save lives.”

Supporting the new design are data from a recent survey Emergent conducted that found that 74 percent of consumers prefer a discreet carrying case over standard packaging, rising to 81% among college students, a population identified as one of the highest-risk groups for opioid misuse.1

While a major step in addressing opioid overdoses was taken with the OTC approval of naloxone nasal spray in 2023, a 2025 survey conducted by RAND and University of South California found that everyday carry rates of the medication remain low, with only 10% of the general consumer population carrying it.2,3

The value and need for carrying OTC naloxone cannot be understated, even for people who would not consider themselves at risk for an opioid overdose, as opioids, especially synthetic opioids, have been found to contaminate a variety of other products and can be consumed without intention. Lucas A. Trautman, MD, MPH, medical director of Oxford Treatment Center, recently discussed some of the risks of taking synthetic opioids hidden in THC vapes, cartridges, and pills, among other substances.

“Not long ago, I admitted a young woman who collapsed minutes after using what she thought was cannabis. Her breathing failed almost instantly. She lived only because someone acted immediately. The toxicology later confirmed a nitazene analog. Her case is not an anomaly. It is a signal,” Trautman said.4

He highlighted the creeping presence of the synthetic opioid nitazene infiltrating THC products and stressed the need for having naloxone on hand and to be prepared for repeat dosing.

“Healthcare professionals must recalibrate their instincts. Any unknown vape exposure should be treated as a potential opioid poisoning until proven otherwise. We cannot rely on assumptions. We must have naloxone immediately available and be prepared for repeated dosing. If an adolescent presents with sudden respiratory collapse and a history of vaping, opioid toxicity belongs at the top of the differential,” he stressed.4

References

1. Emergent BioSolutions Receives U.S. FDA Approval on Supplemental New Drug Application for NARCAN® Nasal Spray to be Packaged in a New Carrying Case, Making Life-Saving Naloxone More Accessible for Everyday Preparedness. News release. Emergent BioSolutions. January 14, 2026. https://www.globenewswire.com/news-release/2026/01/14/3218575/33240/en/Emergent-BioSolutions-Receives-U-S-FDA-Approval-on-Supplemental-New-Drug-Application-for-NARCAN-Nasal-Spray-to-be-Packaged-in-a-New-Carrying-Case-Making-Life-Saving-Naloxone-More-A.html

2. FDA Approves First Over-the-Counter Naloxone Nasal Spray. News release. FDA. March 29, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-over-counter-naloxone-nasal-spray

3. Jacobson M, Powell D. Naloxone Knowledge, Carrying, Purchase, and Use. JAMA Network Open. 2025;8(3):e2462698. doi:10.1001/jamanetworkopen.2024.62698.

4. Trautman L. A Crisis in Disguise: How New Synthetic Opioids Are Infiltrating Popular Substances. Article. HCPLive. December 24, 2025. https://www.hcplive.com/view/crisis-in-disguise-new-synthetic-opioids-infiltrating-popular-substances