NRx Pharma Signs Data Sharing Agreement Related To Patients With Suicidal Bipolar Depression

(RTTNews) - Clinical-stage biopharmaceutical company NRx Pharmaceuticals, Inc. (NRXP) Friday said it has signed a data sharing agreement with the study leadership of a clinical trial of patients hospitalized for Acute Suicidality and Depression in 7 French Government Hospitals.

In this trial, 156 patients were randomized to receive either intravenous racemic ketamine or placebo. The trial had reached its primary endpoint of statistically significant reduction in suicidal ideation and depression. Now, NRx will be able to submit the study results to the FDA as the regulator had requested randomized, placebo-controlled data in support of intravenous ketamine for acute suicidality in the inpatient setting early this year.

NRx said it plans to meet with the 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.