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NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announces Filing of Commissioner's National Priority Voucher Application for Intravenous Ketamine (NRX-100)
Company has applied for new Commissioner's National Priority Vouchers (CNPV) for NRX-100. Continues to anticipate decisions on drug approval by year-end
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"Company has applied for new Commissioner's National Priority Vouchers (CNPV) for NRX-100. Continues to anticipate decisions on drug approval by year-end 2025Application under CNPV program is accretive to already-filed Abbreviated New Drug Application (ANDA) for preservative-free ketamine, with proprietary formulation under priority review requestCompany has received and complied with FDA information request for updated drug ingredient and label information on NRX-100Company has previously filed full Chemical Manufacturing and Controls (CMC) information for NRX-100 with FDA and has reported stability and sterility data sufficient to anticipate three-year room temperature shelf life for preservative-free ketamineWILMINGTON, Del., June 23, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (\"NRx Pharmaceuticals\", the \"Company\"), a clinical-stage biopharmaceutical company, today announced filing for the newly-announced FDA Commissioner's National Priority Voucher program on behalf of NRX-100, its patent-pending, preservative-free formulation of ketamine for intravenous use.\n\n \n \n \n \n \n \n\n \nOn June 17, 2025, FDA Commissioner Marty Makary, MD, MPH announced a new approval pathway, the Commissioner's National Priority Voucher (CPNV)1, for approval of drugs to enhance the health interests of Americans. Previously, on May 25 he identified psychedelic drugs for treatment of suicidal depression and PTSD as a national priority.2 The new voucher may be redeemed by drug developers to participate in a Commissioner-led program that shortens its review time from approximately 10-12 months to 1-2 months following a sponsor's final drug application submission. The new CNPV process convenes experts from FDA offices for a team-based review rather than using the standard review system of a drug application being sent to numerous FDA offices.\nThe FDA plans, in the first year of the program, to give a limited number of vouchers to companies aligned with U.S. national priorities. In addition to receiving the benefits of this program, the agency may also grant an accelerated approval, if the product for which the voucher is used meets the applicable legal requirements for accelerated approval. \nThe FDA Commissioner will use specific criteria to make the vouchers available to companies that are aligned with the national health p...