Suicidal Bipolar Depression: Clinical Trial Results of NRX-101 Found Superior Safety and Similar Efficacy Compared to Lurasidone

People who have bipolar depression face a 50% lifetime risk of attempting suicide and a 20% risk of death from suicide. Over seven million people in the U.S. are struggling with bipolar depression. To date no drugs have demonstrated superiority over the side effects relating to suicide.

In this regard NRx Pharmaceuticals’ (The Company’s) recent announcement via PR Newswire heralds the significant safety advantage of its NRX-101 against the standard of care for people who have suicidal bipolar depression. Although Lurasidone and NRX-101 both exhibited a 50% response in treating depression, NRX-101 proved to be outstanding with a 76% reduction in akathisia symptoms that was maintained over a 42-day period. Akathisia is a side effect of almost all antidepressants and occasionally known to be a side-effect of antipsychotic drugs.

Akathisia is closely associated with suicide as stated in the FDA’s black box warning.

The FDA’s SPA

Using the FDA’s Special Protocol Assessment for guidance to test akathisia levels, NRX Pharmaceuticals announced in PRNewswire that on day 42 NRX-101 levels were at zero.

About 2% of participants receiving NRX-101 compared favorably against 11% of the trial’s participants who were treated with lurasidone. The trial results will be reported at the Clinical Psychopharmacology meeting in Miami May 28-31, 2024.

The Company is seeking Accelerated Approval for NRX-101 based on the safety finding to treat bipolar depression where patients are at risk for akathisia and have the highest suicide risk.

NRx Pharmaceuticals is a biopharmaceutical company that develops therapeutics in accordance with its NMDA platform to treat central nervous system disorders such as suicidal bipolar depression, PTSD and chronic pain.

Rose Duesterwald

Rose Duesterwald

Rose became acquainted with Patient Worthy after her husband was diagnosed with Acute Myeloid Leukemia (AML) six years ago. During this period of partial remission, Rose researched investigational drugs to be prepared in the event of a relapse. Her husband died February 12, 2021 with a rare and unexplained occurrence of liver cancer possibly unrelated to AML.

Follow us