NRx Pharmaceuticals Files for FDA NPV Program on Behalf of NRX-100

NRx Pharmaceuticals has filed for the FDA Commissioner's National Priority Voucher program on behalf of NRX-100, a ketamine formulation for intravenous use. The program aims to expedite the review process from 10-12 months to 1-2 months for priority drugs aligned with national interests. NRX-100 may benefit from accelerated approval and a shorter review time.

NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) has announced its filing for the newly-announced FDA Commissioner's National Priority Voucher (CNPV) program on behalf of NRX-100, its patent-pending, preservative-free formulation of ketamine for intravenous use. The program, which was announced by FDA Commissioner Marty Makary, MD, MPH on June 17, 2025, aims to expedite the review process for drugs that align with U.S. national priorities, potentially reducing the review time from approximately 10-12 months to 1-2 months [1].

The CNPV program is designed to support companies that address critical health crises, deliver innovative cures, meet unmet public health needs, or increase domestic drug manufacturing as a national security issue [2]. NRX-100, which is designed to treat suicidal depression and PTSD, aligns with several of these priorities, including addressing a health crisis and meeting unmet public health needs [3]. NRx Pharmaceuticals believes that NRX-100 meets the criteria for the CNPV program and has submitted the necessary chemistry, manufacturing, and controls (CMC) portion of the application and the draft labeling at least 60 days before the final submission [3].

In addition to the accelerated review time, the CNPV program may also grant an accelerated approval for products that meet the applicable legal requirements. NRx Pharmaceuticals is confident that NRX-100 will benefit from the program and anticipates a decision on drug approval by year-end 2025 [3].

The program is expected to feature prominently in upcoming Prescription Drug User Fee Amendments (PDUFA) negotiations, which are set to begin later this year. The FDA plans to provide additional information about the application process in the near future [2].

References:
[1] https://www.tipranks.com/news/the-fly/nrx-pharmaceuticals-announces-filing-for-fdcs-npv-program-on-behalf-of-nrx-100-thefly
[2] https://www.akingump.com/en/insights/blogs/eye-on-fda/fda-announces-commissioners-national-priority-voucher-program-to-accelerate-drug-application-review-process-and-support-national-priorities
[3] https://www.morningstar.com/news/pr-newswire/20250623cl15658/nrx-pharmaceuticals-inc-nasdaqnrxp-announces-filing-of-commissioners-national-priority-voucher-application-for-intravenous-ketamine-nrx-100