NeuroRx Awarded Fast Track Designation for Regimen Targeting Suicide in Bipolar Depression

NeuroRx has been granted Fast Track status by the U.S. Food and Drug Administration (FDA) for its sequential therapy of NRX-100 (ketamine HCl) followed by NRX-101 (D-cycloserine + lurasidone). The company will begin enrolling patients in a pivotal trial of this sequential therapy targeting patients who are admitted to Emergency Departments with ASIB in bipolar depression.

Fast Track Designation is awarded by the FDA to investigational drugs that are deemed by FDA to treat a serious medical condition and for which there is preclinical and/or clinical data to demonstrate that the drug has the potential to address an unmet medical need. Suicidality in Bipolar Depression is a condition for which there is currently no approved drug therapy and for which the only FDA-approved treatment is Electroconvulsive Therapy (ECT).

Bipolar disorder, which affects 5.7 million Americans, is characterized by significant changes in mood, from mania or hypomania, to depression, often quite severe. The depressive phase, which is called "bipolar depression" can trigger thoughts of suicidal thoughts and behaviors. Standard of care consists of hospitalized observation and electroconvulsive therapy (ECT). Unfortunately, most commonly used antidepressants bear an FDA-mandated warning label identifying the potential to increase the risk of suicide.

Each day, approximately 100 Americans, and more than 2,100 people worldwide, end their lives by suicide, according to American Foundation for Suicide Prevention (AFSP) and the World Health Organization (WHO). Although only 10% of all people with depression have bipolar depression, NeuroRx estimates that bipolar depression accounts for nearly half of all suicides each year.

NRX-101 is a patented, oral, fixed-dose combination of two FDA-approved drugs: d-cycloserine, a N-methyl-D-aspartate (NMDA) receptor modulator, and lurasidone, a 5-HT2a receptor antagonist. NeuroRx's investigational treatment approach begins with a single dose of NRX-100 (ketamine), an FDA-approved anesthetic, for initial stabilization, followed by approximately six weeks of daily oral NRX-101. Results from two Phase II clinical studies, involving 26 and 8 patients respectively, have been published in peer-reviewed journals. Findings showed a 50% reduction in symptoms of depression and a 75% reduction in suicidal ideation in bipolar patients who were on background antidepressant therapy and then treated with d-cycloserine, one of the active ingredients in NRX-101.