According to Emergent BioSolutions, the FDA has accepted the company’s supplemental NDA for over-the-counter (OTC) sales of Narcan naloxone nasal spray for the reversal of opioid overdose and has set a PDUFA goal date of March 29, 2023. The sNDA is for a 4mg dose of Narcan, which is the original strength. In 2017, the FDA also approved a 2 mg dose, which has since been discontinued.
Adapt Pharma, which was later acquired by Emergent, acquired the rights to Narcan from Lightlake Therapeutics (now Opiant Pharmaceuticals) in 2014, and the FDA originally approved the nasal spray in 2015. Adapt launched Narcan in the US in 2016. Two generic versions of Narcan nasal spray have since been approved; Teva launched its version in December 2021, and Padagis launched its version in June 2022.
Emergent BioSolutions President and CEO Robert G. Kramer commented, “As a leader in the fight to help combat the opioid epidemic, Emergent is committed to increasing access and awareness of naloxone, and we are taking this step to help address the rising and devastating number of opioid overdoses and fatalities happening across the country. 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.”
Read the Emergent Biosolutions press release.
