FDA committees take steps to making Narcan available over the counter

On Wednesday, two FDA advisory committees unanimously voted in favor of Narcan nasal spray being made available as an over-the-counter emergency treatment for opioid overdose.

Specifically, the Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee voted 19-0 that the benefit-risk profile of Narcan (naloxone hydrochloride, Emergent BioSolutions) nasal spray is “supportive of its use as a nonprescription opioid reversal agent.”

If approved, it would become the first 4 mg naloxone nasal spray available OTC, according to a press release from Emergent BioSolutions. The company noted that while the FDA is not bound by the committees’ decisions, it will take them under consideration.

According to data from the National Institute on Drug Abuse, there were more than 80,400 overdose deaths in the United States involving opioids of any kind among people of all ages in 2021, up from more than 68,600 in 2020.

Speaking to Healio, Orman Trent Hall, DO, a clinical assistant professor of psychiatry and behavioral health at The Ohio State University Wexner Medical Center, said the vote “may one day be seen as a pivotal moment in America’s struggle against opioid overdose.”

“Such a decisive vote sends an important message that the FDA takes seriously this national health crisis,” Hall, who advised Emergent BioSolutions in preparation for the advisory panel meeting, said. “While we are still awaiting a final decision from the FDA, the fact that the advisory panel was united suggests that naloxone may soon be available over the counter. This would have the potential to dramatically increase the availability of naloxone.”

The FDA previously encouraged companies with prescription naloxone products to apply for OTC switches in November after preliminary findings suggested naloxone nasal spray and autoinjectors could be safely and effectively used without a prescription. Weeks later, the agency granted priority review to a new supplemental drug application for Emergent BioSolutions’s nasal spray.

The vote marks the latest step that the FDA has taken to improve viability and accessibility of naloxone products, which also includes the development of a model Drug Facts Label presenting clear instructions on drug usage and an extension of the nasal spray’s shelf life from 24 to 36 months.

The Prescription Drug User Fee Act goal date for the nasal spray is set for March 29, according to the manufacturer.

“Opioid overdose kills by stopping victims’ breathing. Therefore, it is no exaggeration to say that in the event of overdose naloxone is as important as the air we breathe,” Hall said. “This life saving medication must be readily available when overdose occurs. If the FDA decides to allow over the counter naloxone, lives will be saved.”

References:

• Drug overdose death rates. https://nida.nih.gov/research-topics/trends-statistics/overdose-death-rates. Accessed Feb. 16, 2023.
• Emergent BioSolutions reports FDA Advisory Committees’ unanimous vote in favor of NARCAN® (naloxone HCI) nasal spray for over-the-counter use. https://investors.emergentbiosolutions.com/news-releases/news-release-details/emergent-biosolutions-reports-fda-advisory-committees-unanimous. Published Feb. 15, 2023. Accessed Feb. 16, 2023.
• FDA announces preliminary assessment that certain naloxone products have the potential to be safe and effective for over-the-counter use. https://www.fda.gov/news-events/press-announcements/fda-announces-preliminary-assessment-certain-naloxone-products-have-potential-be-safe-and-effective. Published Nov. 15, 2022. Accessed Feb. 16, 2023.
• February 15, 2023, joint meeting of the NDAC and the AADPAC. https://www.youtube.com/watch?v=QTFU0wHVotM. Published Feb. 15, 2023. Accessed Feb. 16, 2023.