The FDA’s Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee have voted unanimously in favor of over-the-counter use of Narcan naloxone nasal spray for the reversal of opioid overdose. In December 2022, the FDA accepted Emergent BioSolutions’ sNDA for OTC sales of Narcan for priority review, with a PDUFA goal date of March 29, 2023.
Narcan nasal spray was originally approved by the FDA in 2015. Several generic versions of Narcan nasal spray have been available in the US in the past few years, with Teva’s version launched in December 2021 and Padagis’s in June 2022.
Emergent BioSolutions SVP and Products Business Head Paul Williams commented, “This favorable recommendation marks another important step forward to broaden access to Narcan nasal spray for those who may be at risk of an opioid overdose. Today’s vote reaffirms our confidence in the safe and effective use of Narcan in the community setting. We want to thank the participants in the open public hearing who shared their insights and personal experiences informing the need to make Narcan more readily available over the counter.”
Read the Emergent BioSolutions press release.
