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Emergent stock rises as OTC Narcan for opioid overdose reversal gets FDA priority review

  • 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.
  • EBS +8.99% to $12.85 premarket Dec. 6