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NRx Pharmaceuticals Announces Enrollment of First Patient in Phase II Study of Bipolar Depression with Sub-Acute Suicidality
NRx Pharmaceuticals, Inc., enrolled its first patient in one of two psychiatry studies being initiated this year; this first trial is studying patients with
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"NRx Pharmaceuticals, Inc., enrolled its first patient in one of two psychiatry studies being initiated this year; this first trial is studying patients with bipolar depression and sub-acute suicidality (not requiring hospitalization).NRX-101 is a patented, fixed dose combination product of D-cycloserine and lurasidone; both are approved drugs that have not shown abuse potential.It is estimated that up to 50% of individuals with bipolar disorders attempt suicide or have serious thoughts of suicide over their lifetime.NRx Pharmaceuticals plans to start an NRX-101 Phase IIb/III registrational trial in patients with bipolar depression and acute suicidal ideation and behavior (ASIB) (requiring hospitalization) later this year.RADNOR, Pa., May 12, 2022 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (\"NRx Pharmaceuticals\"), a clinical-stage, biopharmaceutical company, today 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 (not requiring hospitalization). 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 (ASIB), 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. \n\n \n \n \n \n \n \n\n \nNRx Pharmaceuticals Announces Dosing of First Patient in NRX-101 Psychiatry Trial for Bipolar Depression with (ASIB)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.\n\"The risk of suicide is very...