NeuroRx's NRX-101, the first oral drug targeting suicidal bipolar depression helps to treat severe bipolar depression with Acute Suicidal Ideation & Behavior (ASIB).
NRX-101 is used for treatment of Severe Bipolar Depression with Acute Suicidal Ideation & Behaviour after initial stabilisation with ketamine or other effective therapy.
NRX-101 (D-cycloserine/lurasidone fixed dose combination) is the first oral drug demonstrated in human volunteers to raise glutamine/glutamate (abbreviated Glx) in the anterior cingulate cortex of the brain on Magnetic Resonance Spectroscopy.
It is a patented, oral, fixed-dose combination of D-cycloserine (DCS), an NMDA antagonist, and lurasidone, which has 5-HT2a receptor antagonist activity.
DCS is shown to raise levels of two neurotransmitters: glutamate and glutamine (Glx). IT primarily raise serotonin levels in the brain.
NRX-101 may represent a new class of antidepressants with the potential to decrease suicidal thoughts, whereas serotonin-based antidepressants are associated with an increase in risk of suicide in certain vulnerable patient populations.
NRX-101 meets the extraordinary unmet medical need that confronts patients with Severe Bipolar Depression.
Patients with bipolar depression are at uniquely high risk for suicide, with more than 50% attempting suicide at some point and up to 20% succumbing to suicide.
NeuroRx is initiating a pivotal Phase 2b/3 clinical trial under the SPA comparing daily oral NRX-101 to standard therapy (lurasidone) in patients with Severe Bipolar Depression and Acute Suicidal Ideation following initial stabilization with ketamine.
Reduced levels of Glx have been reported in multiple studies of patients with depression and PTSD and increased Glx is correlated with improvement in depression as measured by rating scales.
Increased Glx has also been demonstrated with intravenous ketamine and ECT, but not with any known SSRI antidepressant.
NRX-101 is expected to allow treatment on an outpatient basis after an initial stabilization with NRX-100 (ketamine) in a clinical setting.
NRX-101 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA).
