Emergent BioSolutions (NYSE:EBS) recently announced that the FDA accepted for review its over-the-counter Narcan (naloxone HCI) nasal spray.
The FDA last week accepted Emergent’s supplemental new drug application (sNDA) for the Narcan opioid overdose emergency treatment. It also granted the application priority review. If approved, it would represent the first 4 mg naloxone nasal spray available OTC in the U.S.
Gaithersburg, Maryland-based Emergent said the Prescription Drug User Fee Act goal date falls on March 29, 2023.
“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.”
According to Emergent, its FDA submission includes human factor studies conducted on Narcan. It also includes more than five years of post-market data to demonstrate the safe and effective use of the treatment.
The company distributed millions of prescription Narcan devices in the U.S. since garnering approval in 2015. That includes to national, state and local government health departments plus first responders.
“Accidental overdoses can happen to anyone, anywhere, at any time, and by shifting to OTC status, increased access to Narcan will help address patient needs as the opioid epidemic continues to evolve,” the company wrote.