NRx Pharmaceuticals Completes FDA Meeting, Plans to File for NRX-100 New Drug Approval
NRx Pharmaceuticals announced that it has completed an in-person Type C guidance meeting at the headquarters of the US Food and Drug Administration. The meeting was attended by leaders of the FDA Division of Psychiatry Products, the FDA Office of Neuroscience, and the FDA Center for Drug Evaluation and Research. Based on oral guidance received at the meeting, NRx believes it has a path to filing an application for New Drug Approval of NRX-100 based on Substantial Evidence of Effectiveness derived from existing data from adequate and well controlled trials together with confirmatory evidence from more than 65,000 patients identified in the Real World Evidence dataset. NRx will additionally seek a broader indication to serve patients with treatment resistant depression in the context of suicidality, rather than only the subset of patients with suicidality.
