The Food and Drug Administration’s (FDA) Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee unanimously voted in favor (a total of 19 votes) of nonprescription Narcan® (naloxone HCl) Nasal Spray for over-the-counter (OTC) use in the emergency treatment of known or suspected opioid overdose.
Narcan Nasal Spray is an opioid antagonist that reverses the effects of opioids, including respiratory depression, sedation, and hypotension. The FDA approved Narcan Nasal Spray in 2015 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 supplemental New Drug Application (sNDA) for OTC Narcan Nasal Spray was submitted following the FDA’s notice encouraging pharmaceutical manufacturers to develop new nonprescription naloxone products. The application for OTC use is supported by more than 7 years of postmarketing data demonstrating the safety and efficacy of Narcan, along with human factors study data.
In the human factors study, a diverse group of individuals (including low literacy and adolescent participants) were able to successfully administer Narcan Nasal Spray using the nonprescription labeling as a guide when presented with a simulated emergency overdose situation. If approved, the OTC nasal spray would deliver 4mg of naloxone in a single spray device.
“Bystanders are present at nearly half of fatal overdoses, yet naloxone is administered in only a small percentage of those cases,” said Dr Joshua Lynch, Clinical Associate Professor of Emergency and Addiction Medicine, University at Buffalo Jacobs School of Medicine and Biomedical Sciences. “The reality is accidental overdoses can happen to anyone, anywhere, at any time, and we can all do our part by being prepared to help like we would in any other emergency. With access to over-the-counter naloxone, we would have a critical opportunity to close this gap and reduce the number of opioid-related deaths.”
Although not bound by the committees’ recommendations, the FDA does take them into consideration when making decisions on approval. A Prescription Drug User Fee Act target date of March 29, 2023 has been set for the application.
- Emergent BioSolutions reports FDA advisory committees’ unanimous vote in favor of Narcan® (naloxone HCi) nasal spray for over-the-counter use. News release. Emergent BioSolutions. Accessed February 16, 2023. https://investors.emergentbiosolutions.com/news-releases/news-release-details/emergent-biosolutions-reports-fda-advisory-committees-unanimous.
- US Food and Drug Administration. Rx-to-OTC switch for Narcan® (naloxone HCl) Nasal Spray 4 mg: NDA 208411. FDA Briefing Document. February 15, 2023. https://www.fda.gov/media/164666/download.