NeuroRx announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to NRX-101 for the treatment of severe bipolar depression with acute suicidal ideation and behavior after initial stabilization with ketamine or another effective therapy.
NRX-101 combines D-cycloserine (DCS), an N-methyl-D-aspartate (NMDA) receptor antagonist, and lurasidone, a D2/5-HT2a receptor antagonist. Unlike currently approved serotonin-based antidepressants, DCS works by increasing levels of glutamate and glutamine. Currently, the only FDA-approved treatment for suicidal bipolar depression is electroconvulsive therapy (ECT), which has been shown to increase levels of these neurotransmitters.
The Breakthrough Therapy designation was supported by data from the STABIL-B feasibility study which compared the efficacy of NRX-101 vs lurasidone (control). Results showed NRX-101 was well tolerated with no serious adverse events or treatment discontinuations for side effects. More data will be presented at the annual meeting of the American College of Neuropsychopharmacology.
A Phase 2b/3 clinical trial is expected to begin soon; the trial will compare daily NRX-101 with lurasidone in patients with severe bipolar depression and acute suicidal ideation following initial stabilization with ketamine.