NRx Pharmaceuticals Announce Alignment With FDA On Pediatric Study Plan For NRX-100 (ketamine); Remains On Track To File The NDA For NRX-100 In Q4 2024 With Anticipated PDUFA Date In Q2 2025

Author: Benzinga Newsdesk | July 29, 2024 08:46am

• FDA response highlights the importance of addressing suicidal depression in adolescents age 9-17
• Alignment on initial Pediatric Study Plan (iPSP) is a gating requirement for the upcoming filing of an NRX-100 New Drug Application (NDA) for suicidal depression
• NRx remains on track to file the NDA for NRX-100 in Q4 2024 with anticipated PDUFA date in Q2 2025

RADNOR, Pa., July 29, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical stage pharmaceutical company, today announced a communication from the US Food and Drug Administration (FDA) providing feedback and alignment on NRx's proposed initial Pediatric Study Plan (iPSP) for NRX-100 (ketamine) in the treatment of suicidal depression. Congress required the submission of an iPSP as a precondition to filing a New Drug Application in the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA).[1]

Posted In: NRXP