NRx Pharmaceuticals’ NRX-101 eeduces suicidality in bipolar depression trial

NRx Pharmaceuticals announced presentation of its Phase 2b/3 trial of NRX-101 at the American Society of Clinical Psychopharmacology in Miami Beach. Conclusions of the poster include: NRX-101 and lurasidone both demonstrated greater than 50% response for treating bipolar depression with no difference seen on primary efficacy endpoint; a clinically meaningful difference was observed on both primary and secondary safety endpoints favoring NRX-101; NRX-101 was associated with 58% relative reduction in time to sustained remission from suicidality; NRX-101 was associated with a relative 76% reduction in symptoms of akathisia – a side effect in which patients are agitated and frequently experience involuntary movement – vs. lurasidone that was sustained over 42 days; akathisia was seen in 2% of participants treated with NRX-101 vs. 11% treated with lurasidone. No treatment-related serious adverse event was observed in either group. The company believes that NRX-101 has potential to become a standard of care drug for treating bipolar depression. This study represents the second trial conducted under FDA Good Clinical Practices guidelines to demonstrate large and meaningful advantages of NRX-101 vs lurasidone on akathisia and suicidality and clears the path for a registration trial of NRX-101 to treat bipolar depression together with earlier accelerated approval for those with akathisia. To the company’s knowledge, this trial and its prior STABIL-B study represent the only clinical trials in which an oral antidepressant has been demonstrated to cause meaningful reductions in suicidality and akathisia.