The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for Narcan®(naloxone HCl) Nasal Spray as an over-the-counter (OTC) emergency treatment for known or suspected opioid overdose.
Narcan Nasal Spray is an opioid antagonist that reverses the effects of opioids, including respiratory depression, sedation, and hypotension. In 2015, the FDA approved Narcan Nasal Spray as a prescription medication indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. It is also intended for immediate administration as emergency therapy in settings where opioids may be present.
The sNDA for nonprescription use is supported by more than 5 years of postmarketing data demonstrating the safety and efficacy of Narcan, along with human factors studies. If approved, the OTC nasal spray would deliver 4mg of naloxone in a single spray device.
“We look forward to working with the FDA to advance our application under Priority Review designation and believe in the scientific evidence that supports the efficacy and safety of Narcan Nasal Spray as an over-the-counter option for opioid overdose reversal,” said Robert G. Kramer, president and CEO of Emergent BioSolutions.
A Prescription Drug User Fee Act target date of March 29, 2023 has been set for the application.
This article originally appeared on MPR
Emergent BioSolutions announces US FDA acceptance and Priority Review of supplemental New Drug Application for over-the-counter Narcan®(naloxone HCl) Nasal Spray. News release. Emergent BioSolutions. Accessed December 6, 2022. https://www.globenewswire.com/news-release/2022/12/06/2568056/33240/en/Emergent-BioSolutions-Announces-U-S-FDA-Acceptance-and-Priority-Review-of-Supplemental-New-Drug-Application-for-Over-the-Counter-NARCAN-naloxone-HCl-Nasal-Spray.html.