NRx Pharmaceuticals, Inc. announced that the first patient has been enrolled in one of the two psychiatry studies that it plans to initiate this year: this first trial is studying patients with bipolar depression and sub-acute suicidality. In the second half of this year, NRx Pharmaceuticals expects to initiate a Phase IIb/III registrational trial in patients with bipolar depression and acute suicidal ideation and behavior, which requires hospitalization of the patient. The U.S.Food and Drug Administration (FDA) previously awarded Breakthrough Therapy Designation for NRX-101 for this last indication, based on positive Phase II data that the company submitted.

NRX-101 is an oral, patented, fixed-dose combination product of D-cycloserine and lurasidone. D-cycloserine exhibits partial NMDA receptor antagonist activity at specific dosages. Both components are approved drugs that are not scheduled, as available data has not shown potential for abuse.

This is important - as substance abuse can be of great concern when treating individuals with a psychiatric disorder, and especially when they are in a suicidal state. It is estimated that approximately 2.8% of Americans live with bipolar disorder, and up to 4% of adults will be affected by bipolar disorders over their lifespan.