Regulatory First Drug Targeting Suicide in Bipolar Depression Receives FDA Fast Track Status

NeuroRx, a clinical stage biopharma company developing the first oral therapy for Acute Suicidal Ideation and Behavior (ASIB), has been granted Fast Track status by the US Food and Drug Administration for its sequential therapy of NRX-100 (ketamine HCl) followed by NRX-101 (D-cycloserine + lurasidone). The company will shortly begin enrolling patients in a pivotal trial of this sequential therapy targeting patients who are admitted to Emergency Departments with ASIB in bipolar depression.

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