BRIEF—First oral rapid-acting antidepressant to get Breakthrough designation

The US Food and Drug Administration has granted Breakthrough Therapy designation for the development of US biotech NeuroRx’ NRX-101.

The designation is for treatment of severe bipolar depression with acute suicidal ideation and behavior (ASIB) after initial stabilization with ketamine or other effective therapy.

In April, the FDA also issued a Special Protocol Agreement (SPA) for the design of the upcoming pivotal Phase IIb/III clinical trial.

The company recently reported encouraging top- line data from its STABIL-B study, which demonstrated that the drug was well- tolerated with no serious adverse events or discontinuations for side effects.

The FDA decision to award Breakthrough designation to NRX-101 was based in part on clinical data obtained in a multicenter STABIL-B feasibility study designed to evaluate the clinical effect of NRX-101 compared to a lurasidone control group.

These data will be presented next month at the annual meeting of the American College of Neuropsychopharmacology.

NeuroRx is initiating a pivotal Phase IIb/III clinical trial under the SPA comparing daily oral NRX-101 to standard therapy (lurasidone) in patients with severe bipolar depression and acute suicidal ideation following initial stabilization with ketamine.

The FDA previously granted fast track designation for this protocol in 2017.