NRx Pharmaceuticals releases NRX-101 first batches in the U.S.

NRx Pharmaceuticals 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, or PTSD. The company plans to initiate a phase 3 trial targeting bipolar depression in patients with acute suicidal ideation and behavior, or 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.