Posted by Michael Wonder on 15 Nov 2018
NeuroRx receives FDA breakthrough therapy designation for NRX-101, first oral drug targeting suicidal bipolar depression
13 November 2018 - First oral rapid-acting anti-depressant to be granted breakthrough designation.
NeuroRx has been granted breakthrough therapy designation by the U.S. FDA for development of NRX-101. The designation is for treatment of Severe Bipolar Depression with Acute Suicidal Ideation & Behaviour after initial stabilisation with ketamine or other effective therapy.
In April, the FDA also issued a Special Protocol Agreement for the design of the upcoming pivotal Phase 2b/3 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.
