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NRx Pharmaceuticals, Inc. (Nasdaq:NRXP) Announces Completion of Twelve Months of Stability on the First Manufactured Commercial Scale Lot of NRX-100 (Ketamine)
Stability milestone supports submission of FDA New Drug Application by NRx for the use of intravenous ketamine to treat Suicidal DepressionKetamine is
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"Stability milestone supports submission of FDA New Drug Application by NRx for the use of intravenous ketamine to treat Suicidal DepressionKetamine is currently used off-label for this indication. However, FDA approval is typically required for patients to obtain insurance reimbursementNRX-100 is the first preservative-free formulation of Ketamine, potentially avoiding toxic side effects of preservatives used in current preparations designed for single dose anesthetic useRADNOR, Pa., Sept. 30, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, (\"NRx,\" the \"Company\"), today announced that twelve-month real-time stability on the first manufactured lot of NRX-100 (Ketamine) at Nephron Pharmaceuticals, utilizing commercial scale processes, was reached on September 24, 2024. In this process, no degradation of the active ingredient was observed. These findings are consistent with projected room temperature shelf stability in excess of three years. Accelerated stability on additional manufactured lots of preservative-free product is congruent with stability seen in this initial lot.\n\n \n \n \n \n \n \n\n \nDemonstrating the ability to manufacture drug product, and prove its stability, are critical components of the drug approval process with the US FDA. Filing of the NDA for NRX-100 is on track for 2024. The NRX-100 formulation is the first sterile, single dose vial prepared with without the addition of preservatives, which may have toxic effects with repeated use.\n\"We are pleased to reach this important milestone in our preparation of the NDA for NRX-100, a drug we believe can significantly benefit the 3.8 million people who make a plan to commit suicide in the United States each year1,\" said Jonathan Javitt, MD, MPH, Chairman and Chief Scientist of NRx Pharmaceuticals. \"I would like to congratulate the manufacturing team from our partner Nephron Pharmaceuticals for helping us take this important step forward in bringing hope to life.\"\nAbout NRx Pharmaceuticals, Inc.NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain, and PTSD. The Company is developing NRX-101, an FDA-designated investigational ...