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Editorial Advisory Board

  • Professor Andrea M. Armani, University of Southern California
  • Ruti Ben-Shlomi, Ph.D., LightSolver
  • James Butler, Ph.D., Hamamatsu
  • Natalie Fardian-Melamed, Ph.D., Columbia University
  • Justin Sigley, Ph.D., AmeriCOM
  • Professor Birgit Stiller, Max Planck Institute for the Science of Light, and Leibniz University of Hannover
  • Professor Stephen Sweeney, University of Glasgow
  • Mohan Wang, Ph.D., University of Oxford
  • Professor Xuchen Wang, Harbin Engineering University
  • Professor Stefan Witte, Delft University of Technology

NRx Pharmaceuticals Inc. (NASDAQ: NRXP) Secures FDA Fast Track for IV Ketamine Formulation NRX-100 in Suicidal Depression

  • The FDA designation expands the drug’s potential patient pool tenfold, to an estimated 13 million Americans who consider suicide annually.
  • Clinical trials demonstrated rapid and statistically significant reductions in suicidal ideation with IV ketamine versus placebo and comparators.
  • Fast Track status makes NRX-100 eligible for Accelerated Approval and the Commissioner’s National Priority Voucher program.
  • NRx is preparing an expanded access policy and seeking meetings with FDA leadership to align on data submission.
  • The U.S. suicidal depression market is estimated at more than $3 billion annually.

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation to its intravenous ketamine formulation, NRX-100, for the treatment of suicidal ideation in patients with depression, including bipolar depression (https://ibn.fm/LYPf7).

The new designation expands NRX-100’s potential patient population by tenfold compared to the FDA’s 2017 designation, which was limited to use in combination with NRX-101 for suicidal bipolar depression. This expansion also reflects the FDA’s determination that NRX-100 has the potential to address an…

Read More>>

NOTE TO INVESTORS: The latest news and updates relating to NRXP are available in the company’s newsroom at https://ibn.fm/NRXP

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