Business
NRx Pharmaceuticals Produces First Phase 3-stage NRX-101 Drug Made Using Commercial Process
Manufacturing files submitted to U.S. Food and Drug AdministrationThe company has now completed its transition to U.S.-based manufacturingNRX-101 is now
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"Manufacturing files submitted to U.S. Food and Drug AdministrationThe company has now completed its transition to U.S.-based manufacturingNRX-101 is now manufactured via a commercial-stage processRADNOR, Pa., Nov. 9, 2022 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), (\"NRx Pharmaceuticals\" or the \"Company\"), a clinical-stage CNS biopharmaceutical company, today announced the release of the first batches manufactured in the U.S. of NRX-101, its Phase 3-ready investigational drug, targeting suicidal bipolar depression and with future study plans for post-traumatic stress disorder (PTSD). The Company plans to initiate a phase 3 trial targeting bipolar depression in patients with acute suicidal ideation and behavior (ASIB) in the near term. Due to pandemic-related supply chain disruptions, the Company invested in developing commercial manufacturing processes in the U.S. prior to initiating this registrational study. NRx Pharmaceuticals has opted to use this commercial process material in its anticipated registrational clinical study. Having this new manufacturing capability could shorten the time to market availability for NRX-101. A full technology transfer was recently completed, and the corresponding manufacturing file update was submitted to the FDA.\n\n \n \n \n \n \n \n\n \nNRX-101 is a patented, oral, fixed dose combination of D-cycloserine and lurasidone. It is the first oral drug to target suicidal bipolar depression, a significant unmet medical need, as it is estimated that approximately 50% of the 7 million individuals with bipolar disorder in the U.S. attempt suicide over their lifetime, mostly during the depressive phases. The only FDA-approved treatment for this condition is electroshock therapy. Currently approved drugs for bipolar depression carry a warning of a potential increase in the risk of suicide in certain populations.\nThe Company completed an initial phase 2 trial of NRX-101 in 2018 and demonstrated a statistically significant reduction in both measures of depression (P","length":2965,"tagName":"div"}]