NeuroRx, a clinical stage biopharma company has been granted Fast Track status by the US Food and Drug Administration for patients admitted to emergency departments with AISB bipolar depression.
NeuroRx is an Israeli company with an office in Wilmington.
The company will begin enrolling patients in a pivotal trial.
No drug therapy exists for the condition that can lead to suicide.
Jonathan Javitt, M.D., will update investors this week on the company’s progress.
Bipolar disorder, which affects 5.7 million Americans, is characterized by significant changes in mood, from mania or hypomania, to severe depression.
The depressive phase, which is called “bipolar depression” can trigger thoughts of suicidal thoughts and behaviors.
Standard of care consists of hospitalized observation that consists of small electrical currents going through brain.
The company also noted that 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).
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.
Results from two Phase II clinical studies, involving 26 and 8 patients respectively, have been published in peer-reviewed journals. Findings showed a 50 percent 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 the NeuroRX drug.
NeuroRx is privately funded and led by former senior executives of Johnson and Johnson, Pfizer, Lilly, and Bristol Meyer Squibb.