An Open Label Study of NRX-101 for Patients With Acute Complicated Urinary Tract Infection Including Pyelonephritis
The goal of this clinical study is to test NRX101 in participants with complicated urinary tract infections including pyelonephritis. The main questions it aims to answer are: Does NRX101 help participants resolve UTIs? Is NRX101 safe for participants with UTIs? Participants will be seen in a doctor's office approximately 6 times to: Answer a short 10 item questionnaire. Review of side effects Urine tests Blood draw (about 10 ml or 2 teaspoons) Review of medications Review any signs or symptoms of UTI Vital signs and weight (including blood pressure, heart rate, respiratory rate, and temperature) Review of medical history This is an open-label study of NRX101, which means both you and your doctor know what drug you are taking. After the study is completed, researchers will look at the data to see if NRX101 helps participants with complicated UTI's.
A Randomized, Double-Blind Controlled Comparison of NRX-101 to Lurasidone for Adults With Bipolar Depression and Subacute Suicidal Ideation or Behavior
NMDA antagonist drugs have shown to reduce symptoms of depression and suicidal ideation. NeuroRx has developed NRX-101 (fixed dose combination of D-cycloserine and lurasidone) for oral use in the treatment of bipolar depression with suicidal ideation. This study will test the hypothesis that NRX-101 is superior to lurasidone alone (standard of care) in maintaining remission from symptoms of depression (primary endpoint) and suicidal ideation or behavior (declared secondary endpoint) over a six week period of twice-daily oral dosing.
NRX-101 for Maintenance of Remission From Severe Bipolar Depression in Patients With Acute Suicidal Ideation and Behavior: The SBD-ASIB Study
NMDA antagonist drugs have increasingly been demonstrated to reduce symptoms of depression and suicidal ideation. NeuroRx has developed a sequential therapy consisting of IV NRX-100 (ketamine HCL) for rapid stabilization of symptoms of depression and suicidal ideation followed by oral NRX-101 (fixed dose combination of D-cycloserine and lurasidone) for maintenance of stabilization from symptoms of depression and suicidal ideation. NRX-101 has been awarded Fast Track and Breakthrough Therapy Designation by the US Food and Drug Administration. The SevereBD study will test the hypothesis that NRX-101 is superior to lurasidone alone in maintaining remission from symptoms of depression (primary endpoint), clinical relapse (declared secondary endpoint), and suicidal ideation or behavior (declared secondary endpoint) over a six week period of twice-daily oral dosing.