BioMedNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Applies for FDA Commissioner’s Priority Voucher for NRX-100 Ketamine Formulation
NRx Pharmaceuticals (NASDAQ: NRXP) has filed for the newly launched FDA Commissioner’s National Priority Voucher (CNPV) program, seeking accelerated review for NRX-100, its preservative-free intravenous ketamine formulation. The company believes NRX-100 meets all criteria outlined by FDA Commissioner Marty Makary, who announced the voucher program on June 17, 2025, to prioritize treatments aligned with urgent U.S. health needs—including suicidal depression and PTSD. NRx has already submitted the chemistry, manufacturing, and controls (CMC) portion of its application and received FDA feedback, placing it on track for potential accelerated review of its full New Drug Application (NDA) by late 2025. If granted,…
