The U.S. Food and Drug Administration (FDA) granted priority review to Emergent BioSolutions (NYSE:EBS) application for Narcan (naloxone HCI) Nasal Spray as an over-the-counter (OTC) therapy to reverse opioid overdose.
The FDA accepted the company's supplemental new drug application (sNDA) and is expected to make a decision by March 29, 2023. Under priority review, the FDA's goal is to take action within six months, compared to 10 months under standard review.
The company said its submission to the FDA includes Human Factors studies, and more than five years of post-marketing data to show the safe and effective use of Narcan.
Since its approval in 2015, Emergent has distributed millions of prescription Narcan devices across the U.S., the company added.
Emergent noted that its sNDA is the first prescription-to-over-the-counter switch application in history to be granted priority review by the FDA.
