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NRx Pharmaceuticals Announces FDA Permission to Proceed on Investigational New Drug (IND) Application for NRX-101 to Treat Chronic Pain
Allows initiation of the NRX-101 commercial development to treat Chronic PainCompany plans to seek Fast Track and Breakthrough Therapy Designations from FDA
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"Allows initiation of the NRX-101 commercial development to treat Chronic PainCompany plans to seek Fast Track and Breakthrough Therapy Designations from FDA while awaiting near-term results of Dept of Defense-funded trialRADNOR, Pa., Oct. 2, 2023 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (\"NRx Pharmaceuticals\", the \"Company\"), a clinical-stage biopharmaceutical company, today announced that FDA has given the company clearance to proceed with human trials to treat Chronic Pain under the Investigational New Drug (IND) application filed with the U.S. Food and Drug Administration (FDA) for the use of NRX-101. 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.\n\n \n \n \n \n \n \n\n \n\"More than one in five adults in the United States suffers from chronic pain and patients lack options that do not carry the risk of addiction and opioid side effects. We are pleased that our IND was cleared for initiation of clinical trials within 30 days of filing and we look forward to initiating commercial development of NRX-101 to treat chronic pain,\" said Dr. Jonathan Javitt, Founder, Chairman and Chief Scientist of NRx Pharmaceuticals, Inc. \"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 this critical indication.\" \nDr. Javitt continued \"As we have already completed critical manufacturing activities to support our program in suicidal depression, we have sufficient quantities of our investigational drug on hand to launch registrational studies for Chronic Pain in 2024, pending the results of the recently completed clinical trial funded by the US Department of Defense.\"\nNRX-101 in Chronic Pain\nChronic pain is estimated to be a $72 billion industry today with the potential to grow to a $120 billion industry by 2033.In June 2023, concurrent with announcement of the Alvogen partnership, the Company announced an expansion of its NRX-101 program to encompass treatment of chronic pain as the next focus on NRX-101's development.The company has announced the licensure of US Paten...