Results from NeuroRx’s STABIL-B trial, a phase 2 study performed under FDA Good Clinical Practices (GCP) were presented at the American College of Neuropsychopharmacology in December 2019.  On the basis of these findings, the FDA awarded Breakthrough Therapy Designation to NRX-101.

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*These drugs are investigational and not approved by the US FDA

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Clinical Data

Results from NeuroRx’s STABIL-B trial, a phase 2 study performed under FDA Good Clinical Practices (GCP) were presented at the American College of Neuropsychopharmacology in December 2019.  On the basis of these findings, the FDA awarded Breakthrough Therapy Designation to NRX-101.

 

In this trial, 20 patients who presented to emergency care with Severe Bipolar Depression and Acute Suicidal Ideation were initially stabilized with a single infusion of intravenous ketamine (NRX-100).  Study details may be seen on www.clinicaltrials.gov.1

 

Following stabilization, patients were randomly assigned (2:1) to either NRX-101 or to lurasidone alone in order to maintain remission from depression and suicidal ideation.  As can be seen in the top-line analysis shown below, those treated with NRX-101 demonstrated a significantly lower level of depression at 14 days, compared to those treated with lurasidone (P=0.03).  This trend was seen to persist at 42 days (P=0.059).

Relapse in either depression or suicidality was seen in 2/5 control patients treated with lurasidone, while no instances of relapse were seen in patients treated with NRX-101, (P=.095).  No drug-related serious adverse events were observed and no instances of hallucination were seen in the oral drug phase of the study.

 

Findings a prior study were published in the Journal of Clinical Psychiatry in 2015. In this study, patients with Bipolar Depression, who were already receiving a 5-HT2a antagonist, received a single infusion of IV ketamine followed by daily, oral D-cycloserine. Results showed a >50% reduction in symptoms of depression and a 75% reduction in suicidal ideation. The therapeutic effect for these patients was sustained for eight weeks or longer.2

 

Preclinical data showing that the combination of lurasidone (and other 5HT2a antagonists) and D-cycloserine led to a significant reduction in akathisia compared to control and to lurasidone alone. These findings are described in detail in several US and ex-US patent filings. Akathisia is defined as a state of agitation, distress, and restlessness that is an occasional side-effect of antipsychotic and antidepressant drugs.

 

 

 

  1. https://www.clinicaltrials.gov/ct2/show/NCT02974010?term=stabil-b&rank=1
  2. Kantrowitz, et al: J Clinical Psychiatry 2015; 76(6): 737-738