NRx plans to file a new-drug application for IV ketamine in early 2024.
NRx Pharmaceuticals announced that it has signed an 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,” NRx said in a news release.
In the randomized clinical trial, adults with current major depressive disorder and a score ≥4 on the Scale for Suicidal Ideation (SSI), of whom 54% were taking antidepressant medication, were randomly assigned to receive ketamine or midazolam infusion, as explained in the American Journal of Psychiatry.
In the trial, Dr. Michael Grunebaum and colleagues demonstrated a rapid and statistically significant reduction in 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.
NRx noted that the data mirror the results recently reported by a French consortium of hospitals that tested ketamine versus a placebo in acutely suicidal patients. NRx established a similar data-licensing agreement in September. The study results were published in the British Medical Journal.
NRx said the company and its regulatory counsel believe that the two aforementioned trials “meet the regulatory standard” for the filing of a new-drug application in early 2024. The filing will include manufacturing and stability data from the company’s partnership with Nephron Pharmaceuticals in West Columbia, South Carolina.
“We at NRx are delighted to partner with the thought leaders at Columbia University to help seek FDA approval for this extraordinary public health need,” said Dr. Jonathan Javitt, founder and chief scientist of NRx Pharmaceuticals. “Until now, the only FDA-approved treatment for suicidal depression has been electroshock therapy (ECT). Recent literature suggests that ketamine may actually be superior to ECT in reducing suicidal ideation, while certainly having a more benign side-effect profile.
“Although ketamine is widely used off-label in the United States and is considered standard of care by some professionals, until it is labeled for treating depression and suicidality, it will be widely accessible only to those patients able to pay out of pocket for their care and will continue to be subject to various warnings about off-label use of a controlled substance.”