NRx Pharmaceuticals Applies for FDA National Priority Voucher for Intravenous Ketamine (NRX-100)

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BREAKING NEWS

A new formulation of ketamine is progressing through a novel US Food and Drug Administration review pathway, announced NRx Pharmaceuticals. The company has applied for a Commissioner’s National Priority Voucher (CNPV) for NRX-100, its patent-pending, preservative-free intravenous ketamine. NRx concurrently is preparing a New Drug Application (NDA) for the treatment of suicidal depression and PTSD. The company continues to anticipate an FDA decision on NRX-100 by the end of 2025.¹

The newly announced CNPV pathway was introduced by FDA Commissioner Marty Makary, MD, MPH, on June 17, 2025, and is intended to expedite reviews for medications that address US public health priorities. The voucher program allows eligible applications to be reviewed in as little as 1 to 2 months, compared to the standard 10 to 12 months, through a Commissioner-led, team-based approach rather than the traditional system which entails the application being routed and reviewed by various FDA offices.²

In a press release, NRx Pharmaceuticals said NRX-100 is well positioned for this designation, citing its alignment with national health priorities such as addressing the mental health crisis, innovating treatment for unmet needs, and enhancing domestic drug manufacturing. “NRx is highly encouraged by the newly-announced Commissioner's National Priority Voucher Program, and believes that NRX-100 meets each of the criteria for acceptance,” Jonathan C. Javitt, MD, MPH, chairman and chief executive officer of NRx, said in the company's announcement.¹

The company has previously filed the required Chemistry, Manufacturing, and Controls (CMC) information and received FDA feedback. NRx supplied the FDA with requested information on ketamine Active Pharmaceutical Ingredient and final proposed labeling language.¹

"As previously determined by FDA, our products are innovative treatments that address the current health crisis of suicidal depression and PTSD, and address an unmet medical need," Javitt added. "We will be seeking New Drug Approval for NRX-100 in the treatment of suicidal depression and PTSD. The FDA's announcement has now validated our Company's focus on manufacturing and CMC by identifying CMC as a pre-requisite to the CNPV program. The timelines announced for the CNPV program are consistent with NRx's previous guidance of FDA decisions (PDUFA date) by year-end 2025. Our application under the CNPV program is accretive to the Abbreviated New Drug Application filed last week for preservative-free ketamine, for which we are seeking priority review."¹

Additionally, the company plans to file a citizen petition with the FDA to withdraw preservative-containing forms of ketamine, citing concerns about benzethonium chloride toxicity. A recently filed patent on its preservative-free manufacturing process may further support market exclusivity.¹

NRx appears to be committed to the mental health space. It recently submitted an Abbreviated New Drug Application (ANDA) for NRX-100, the preservative-free intravenous ketamine formulation, for existing FDA-approved indications of ketamine. Similarly, the company initiated an NDA process for NRX-100 as a treatment for suicidal depression, which was based on data from well-controlled clinical trials conducted by the US National Institutes of Health as well as newly acquired data from French health authorities under a data-sharing agreement. The FDA has granted Fast Track Designation to NRX-100 for the treatment of acute suicidality, and NRx has also filed a patent application for its novel preservative-free formulation with the US Patent and Trademark Office.¹

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References

1. NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announces Filing of Commissioner's National Priority Voucher Application for Intravenous Ketamine (NRX-100). Press release. June 23, 2025. Accessed June 23, 2025. https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-inc-nasdaqnrxp-announces-filing-of-commissioners-national-priority-voucher-application-for-intravenous-ketamine-nrx-100-302487956.html
2. FDA. FDA to Issue New Commissioner’s National Priority Vouchers to Companies Supporting U.S. National Interests. Press release. June 17, 2025. Accessed June 23, 2025. https://www.fda.gov/news-events/press-announcements/fda-issue-new-commissioners-national-priority-vouchers-companies-supporting-us-national-interests