NRx Pharmaceuticals announces filing for FDC’s NPV program on behalf of NRX-100

NRx Pharmaceuticals (NRXP) announced filing for the newly-announced FDA Commissioner’s National Priority Voucher, NPV, program on behalf of NRX-100, its patent-pending, preservative-free formulation of ketamine for intravenous use. On June 17, 2025, FDA Commissioner Marty Makary, MD, MPH announced a new approval pathway, the Commissioner’s National Priority Voucher, for approval of drugs to enhance the health interests of Americans. 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 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.