NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, today announced that it has signed a License Data and Technical Information Agreement with Columbia University for rights to data from a randomized, active-controlled trial of 80 patients hospitalized for Acute Suicidality in Depression. This represents NRx's second well-controlled trial demonstrating the efficacy of IV Ketamine in this indication.
In this trial, Dr. Michael Grunebaum and colleagues demonstrated a rapid and statistically significant reduction in Suicidal Ideation (SSI) at day 1 (p=0.0003) and in depression (P=0.0234), as measured by the Profile of Mood States (POMS) among patients randomized to IV Ketamine compared to those randomized to midazolam. This trial was published in the American Journal of Psychiatry https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5880701/.
These data mirror the results recently reported by a French consortium of hospitals who tested ketamine vs. placebo in acutely suicidal patients. NRx established a similar data licensing agreement in September, 2023 (NRx Ketamine Data Sharing, France). The study was published in the British Medical Journal (BMJ 2022; 376 doi: https://doi.org/10.1136/bmj-2021-067194).
The company and its regulatory counsel believe these two well-controlled trials meet the regulatory standard for a New Drug Application (NDA) filing in early 2024. This filing will include manufacturing and stability data from the Company's partnership with Nephron Pharmaceuticals (West Columbia, SC).
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