FDA Grants Fast Track Status to Oral Treatment for Acute Suicidal Ideation

Girl sitting and looking down
Girl sitting and looking down
NRX-100 followed by NRX-101 has been granted Fast Track status by the Food and Drug Administration.

NeuroRx has announced that its oral sequential therapy – NRX-100 (ketamine HCl) followed by NRX-101 (d-cycloserine and lurasidone) – for acute suicidal ideation and behavior (ASIB) has been granted Fast Track status by the Food and Drug Administration (FDA).

NRX-101 is a patented, fixed-dose combination of d-cycloserine, an N-methyl-D-aspartate (NMDA) receptor modulator, and lurasidone, a 5-HT2a receptor antagonist. The treatment involves an initial single dose of NRX-100 followed by approximately six weeks of daily oral NRX-101. NeuroRx is planning to begin a pivotal trial of the therapy this October. The researchers plan to enroll patients who are admitted to emergency departments with ASIB in bipolar depression.

Results from two previous Phase 2 trials of NeuroRx’s sequential treatment have shown a 50% reduction in symptoms of depression and a 75% reduction in suicidal ideation in bipolar patients.

There is currently no approved drug to treat suicidality in bipolar depression. The only approved treatment is electroconvulsive therapy (ECT). 

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NeuroRx awarded FDA Fast Track Designation for first drug regimen targeting suicide in bipolar depression.  http://www.neurorxpharma.com/assets/2017-09-06-neurorx-fast-track-release.pdf. Sept 6, 2017

This article originally appeared on MPR