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NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announces FDA Award of Filing Fee Waiver for Upcoming NRX-100 (preservative free ketamine) New Drug Application to Treat Patients with Suicidal Depression
Waiver exempts NRx from paying a $4.3 million New Drug Application filing fee under the Prescription Drug User Fee Act (PDUFA)Company is on track for Q2 2025
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"Waiver exempts NRx from paying a $4.3 million New Drug Application filing fee under the Prescription Drug User Fee Act (PDUFA)Company is on track for Q2 2025 completion of NDA filing and PDUFA date by year end with currently available corporate resourcesNRX-100, together with NRX-101, was granted Fast Track designation by FDA for treatment of suicidal bipolar depression in 2018Company notes recent statements by Secretary of Health and Human Services regarding the public health importance of approving psychedelic drugs such as ketamine to treat suicidal depression and PTSDMIAMI, April 30, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc., (Nasdaq:NRXP or \"the Company\"), today announced the grant of a filing fee waiver by the US Food and Drug Administration (\"FDA\") to exempt the Company from a $4.3 million fee to file its New Drug Application for NRX-100 (preservative-free ketamine). The waiver is granted at the discretion of the FDA to Small Business Entities and for drugs that are deemed to be necessary for Public Health. The Company anticipates that this waiver enables the completion of its New Drug Application for NRX-100 with currently-available corporate resources. The NDA filing is anticipated by the end of the second quarter of this year (Q2 2025).\n\n \n \n \n \n \n \n\n \nNRX-100 is a preservative-free preparation of ketamine in a single-patient presentation. Currently-available forms of ketamine contain preservative – benzethonium chloride – the safety of which has never been demonstrated for repeated use. The preservative was added in the 1970s when ketamine was originally formulated as an anesthetic and the practice at the time was to package anesthetic drugs in multi-use vials that required a preservative to maintain sterility. Although benzethonium chloride has not demonstrated toxicity in anesthesia, this class of preservatives has been shown to be neurotoxic and cytotoxic to the tissues of the eye when incorporated in eye drops. NRx has now demonstrated stability and sterility sufficient to maintain more than two years of shelf life in a preservative-free presentation. This patent-pending process is anticipated to yield long-term exclusivity should NRX-100 be approved by the FDA.\nAs previously announced, NRx will be submitting data from controlled clinical trials that demonstrate ketamine to be superior to both ...