NRx Pharmaceuticals signs data sharing agreement for ketamine treatment

NRx Pharmaceuticals announced that it has signed a data sharing agreement with the study leadership of a randomized, placebo-controlled trial of 156 patients hospitalized for Acute Suicidality and Depression in 7 French Government Hospitals. This trial, conducted under International Good Clinical Practices and Helsinki standards demonstrated a statistically-significant reduction in suicidal ideation and depression among patients randomized to intravenous racemic ketamine, compared to those randomized to placebo. The trial reached its primary endpoint for all patients and demonstrated the largest effect among the subgroup with bipolar depression. The top line data from this trial were published in the British Medical Journal and additional data reports are planned. The efficacy demonstrated confirms earlier, smaller trials conducted in the United States and elsewhere. As disclosed previously, NRx met with the FDA in January 2023 at which time the FDA requested randomized, placebo-controlled data in support of intravenous ketamine for acute suicidality in the inpatient setting. Such trials are extraordinarily complex to organize and generally require Government support. In this case, NRx approached the Fondation FundaMental, led by Marion Leboyer, who served on the NRx Scientific Advisory Board and facilitated establishing the current Data Sharing Agreement. Under this agreement, NRx has translated the clinical study report, which will be submitted to FDA and is converting the electronic, patient level data files to a form suitable for FDA review. NRx plans to meet with FDA in the coming months to discuss a regulatory path for the use of ketamine to treat patients with Bipolar Depression and Acute Suicidal Ideation and Behavior.