Therapy Areas: Central Nervous System
NRx Pharmaceuticals signs data agreement with Columbia University for IV Ketamine trials
19 December 2023 -

NRx Pharmaceuticals Inc (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, announced on Tuesday that it has entered into a License Data and Technical Information Agreement with Columbia University. The agreement grants NRx access to data from a well-controlled trial involving 80 patients hospitalised for Acute Suicidality in Depression, marking the company's second trial supporting the efficacy of IV Ketamine for suicidal depression.

Results from the trial, led by Dr Michael Grunebaum, reveal a significant reduction in Suicidal Ideation (SSI) at day 1 (p=0.0003) and in depression (p=0.0234), compared to an active comparator. NRx plans to present the data from both trials to the FDA in q1 2024 to support a New Drug Application.

The company is actively developing therapeutics based on its NMDA platform, with a focus on central nervous system disorders such as suicidal bipolar depression, chronic pain and PTSD.

Designated an FDA investigational Breakthrough Therapy, NRX-101 is a potential treatment for suicidal treatment-resistant bipolar depression and chronic pain. The company's partnership with Alvogen Pharmaceuticals supports the development and marketing of NRX-101 for suicidal bipolar depression, with additional potential as a non-opioid treatment for chronic pain.

NRx aims to submit a New Drug Application for ketamine in the treatment of suicidal depression, leveraging well-controlled clinical trials conducted under the US National Institutes of Health and newly acquired data from French health authorities. NRx was granted Fast Track Designation by the US FDA for the development of ketamine (NRX-100) in treating patients with acute suicidality.