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NRx Pharmaceuticals Announces Submission of an Investigational New Drug (IND) Application for NRX-101 in the Treatment of Chronic Pain
IND builds on previously-published, preliminary evidence of efficacyFiling is supported by robust manufacturing, pre-clinical and clinical data already
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"IND builds on previously-published, preliminary evidence of efficacyFiling is supported by robust manufacturing, pre-clinical and clinical data already reviewed by FDA for NRX-101 associated with treatment of bipolar depressionRADNOR, Pa., Aug. 30, 2023 /PRNewswire/ - NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (\"NRx Pharmaceuticals\", the \"Company\"), a clinical-stage biopharmaceutical company, today announced submission an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the use of NRX-101 to treat Chronic Pain. The IND application leverages pioneering research on the use of D-cycloserine (a key ingredient of NRX-101) in the treatment of chronic pain and the recent licensure by NRx of a US Patent for the use of D-cycloserine in the treatment of pain. Nonclinical and substantial clinical data are already on file with FDA for NRX-101, which has already been granted Breakthrough Therapy Designation for the treatment of suicidal Bipolar Depression.\n\n \n \n \n \n \n \n\n \n• IND builds on previously-published, preliminary evidence of efficacy • Supported by robust data\"One in five American adults suffers from chronic pain, a condition for which there are few good solutions, once NSAIDs and Tylenol-like drugs have been exhausted. There is a critical need for non-addictive, non-neurotoxic, oral medicines, particularly with the widespread recognition that opioids are not a viable option for treatment,\" said Dr. Jonathan Javitt, Founder, Chairman and Chief Scientist of NRx Pharmaceuticals, Inc. \"NRX-101 targets the NMDA receptor in the brain, which has been demonstrated in extensive nonclinical and early clinical studies to mediate the pain pathway.\"\nDr. Javitt continued \"based on the preliminary evidence of efficacy already demonstrated for the use of D-cycloserine in Chronic Pain, we plan to seek Fast Track Designation, Priority Review, and Breakthrough Therapy Designation for the use of NRX-101 to treat Chronic Pain. We have already completed the critical manufacturing components required by FDA in connection with our bipolar depression program and have sufficient quantities of our investigational drug on hand to launch registrational studies in 2024, pending the results of the recently completed clinical trial funded by the US Department of Defense.\"\nNRX-101 in Chronic Pain\nChr...