FDA Grants Fast Track Status to Oral Treatment for Acute Suicidal Ideation
There is currently no approved drug to treat suicidality in bipolar depression.
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).
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