Suicide drug gets FDA fast track
NeuroRx, a Wilmington biopharmaceutical company, has been granted fast-track status by the U.S. Food and Drug Administration for an experimental treatment for suicidal behavior.
The company will begin enrolling patients in its sequential oral therapy targeting patients admitted to emergency departments with “acute suicidal ideation behavior” in bipolar depression.
The FDA awards Fast Track Designation to experimental drugs the agency deems useful to treat a serious medical condition and fill an unmet medical need.
There is currently no approved drug therapy for suicidal behavior in bipolar depression.
Dr. Jonathan Javitt, CEO of NeuroRx, will update investors on the company’s upcoming clinical trial at the Rodman and Renshaw Global Investment Conference on Monday and Tuesday in New York City.
NeuroRx is privately funded and led by former senior executives of Johnson and Johnson, Pfizer, Lilly, and Bristol Meyer Squibb.