NRx Pharmaceuticals, Inc. announced the filing of an application for the newly-announced FDA Commissioner's National Priority Voucher (CNPV) program for NRX-100, its patent-pending, preservative-free formulation of intravenous ketamine. This program, announced by FDA Commissioner Marty Makary on June 17, 2025, offers a shortened review time from approximately 10-12 months to 1-2 months following final drug application submission.
The CNPV program is designed for drugs that enhance the health interests of Americans and are aligned with U.S. national priorities, such as addressing suicidal depression and PTSD. NRx believes NRX-100 meets these criteria, having already submitted the chemistry, manufacturing, and controls (CMC) portion of the application.
The company's application under the CNPV program is accretive to its recently filed Abbreviated New Drug Application (ANDA) for preservative-free ketamine. This initiative could significantly accelerate the availability of NRX-100, which is being developed to treat suicidal depression and PTSD, and potentially lead to accelerated approval.
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