Emergent BioSolutions’ supplemental New Drug Application (sNDA) for NARCAN (naloxone HCI) Nasal Spray, as an over-the-counter (OTC) emergency treatment for opioid overdose, has accepted for review by the U.S. FDA. The application was granted Priority Review by the FDA and, if approved, would be the first 4 mg naloxone nasal spray available OTC in the U.S. The Prescription Drug User Fee Act goal date is March 29, 2023.
 
The opioid epidemic is an ongoing national public health issue and has been exacerbated by the escalating use of synthetic opioids, namely fentanyl. According to the Centers for Disease Control and Prevention, deaths related to synthetic opioids increased nearly 60 percent from 2019 to 2020, and in 2021 alone, more than 71,000 people died from opioids containing fentanyl.
 
“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,” said Robert G. Kramer, president and CEO of Emergent BioSolutions. “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.”
 
Emergent’s submission to the FDA includes Human Factors studies conducted, as well as more than five years of post-marketing data to demonstrate the safe and effective use of NARCAN. Since its approval in 2015, Emergent has distributed millions of prescription NARCAN devices.