RADNOR, PA — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) has made a significant step forward in its quest to secure regulatory approval for Intravenous (IV) Ketamine as a treatment for acute suicidality in depression. The company recently signed a License Data and Technical Information Agreement with Columbia University, gaining rights to data from a randomized, active-controlled trial involving 80 patients.
This agreement follows on the heels of a similar arrangement established in September 2023 with a French consortium of hospitals. Together, these two agreements provide NRx with valuable data from well-controlled trials demonstrating the efficacy of IV Ketamine in treating acute suicidality in depression.
Dr. Michael Grunebaum and his team at Columbia University found that patients given IV Ketamine displayed a rapid and statistically significant reduction in Suicidal Ideation (SSI) and depression within one day of treatment, outperforming those given midazolam. These findings echo the results reported by the French consortium.
Based on these successful trials, NRx and its regulatory counsel are confident that they meet the regulatory standards necessary for a New Drug Application (NDA) filing, expected in early 2024. The application will also include manufacturing and stability data from their partnership with Nephron Pharmaceuticals.
“Until now, the only FDA-approved treatment for suicidal depression has been electroshock therapy (ECT),” said Dr. Jonathan Javitt, Founder and Chief Scientist of NRx Pharmaceuticals. “Recent literature suggests that ketamine may actually be superior to ECT in reducing suicidal ideation, while certainly having a more benign side effect profile.”
Javitt also highlighted the accessibility issue, noting that until ketamine is officially labeled for treating depression and suicidality, it will remain widely accessible only to those patients able to pay out of pocket for their care. It will also continue to be subject to warnings about off-label use of a controlled substance.
With these agreements, NRx Pharmaceuticals is poised to make a significant contribution to public health by potentially providing an effective and more accessible treatment option for patients grappling with suicidal depression.
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