Oral Therapy for Suicidal Bipolar Depression Gets Breakthrough Designation

The Breakthrough Therapy designation was supported by data from the STABIL-B feasibility study
The Breakthrough Therapy designation was supported by data from the STABIL-B feasibility study

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.

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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.

For more information visit NeuroRxpharma.com.