NRx Pharmaceuticals Presents Landmark NRX-101 Trial for Suicidal Bipolar Depression at ASCP Meeting

NRx Pharmaceuticals, a clinical-stage pharmaceutical company, has shared promising results from its Phase 2b/3 trial of NRX-101. The study, titled "A Randomized, Double-Blind Controlled Comparison of NRX-101 (D-cycloserine/lurasidone) to Lurasidone for Adults with Bipolar Depression and Subacute Suicidal Ideation or Behavior," was presented at the American Society of Clinical Psychopharmacology (ASCP) in Miami Beach, FL. The investigation was led by Professor Andrew Nierenberg from Massachusetts General Hospital and Harvard Medical School.

NRX-101, a combination of D-cycloserine and lurasidone, is being evaluated for its effectiveness in treating bipolar depression and reducing suicidality. According to the trial outcomes, NRX-101 matched the antidepressant efficacy of lurasidone, the current standard treatment, with both demonstrating approximately a 50% reduction in MADRS scores. More significantly, NRX-101 showcased superior results in key safety metrics.

The trial revealed that NRX-101 resulted in a 58% faster transition to sustained remission from suicidal ideation and behavior compared to lurasidone, as measured by the Columbia Suicide Severity Rating Scale (C-SSRS). This demonstrates a significant improvement (P=0.05) and highlights the potential of NRX-101 to rapidly alleviate suicidality.

In addition to its impact on suicidality, NRX-101 also showed a remarkable 76% reduction in symptoms of akathisia compared to lurasidone over 42 days, measured by the Barnes Akathisia Rating Scale. Akathisia, a condition characterized by a feeling of inner restlessness and a compulsion to move, is a side effect commonly associated with antipsychotic medications and is linked to an increased risk of suicide. The trial found that akathisia was present in only 2% of patients on NRX-101, compared to 11% on lurasidone, with effects noticeable as early as day 7 of the treatment.

No serious adverse events related to the treatment were observed in the trial, confirming the safety of NRX-101. Minor safety concerns were noted, such as general disorders, which were higher in the NRX-101 group (18.2%) compared to none in the lurasidone group (p=0.002).

Dr. Jonathan Javitt, Chairman and Chief Scientist of NRx, expressed optimism about the potential of NRX-101 to transform the treatment landscape for bipolar depression. He highlighted the dual benefits of treating depression and reducing associated suicidality and akathisia, which could offer new hope to patients.

This trial is the second study to demonstrate the benefits of NRX-101 under FDA Good Clinical Practices guidelines, building on the earlier STABIL-B trial. Collectively, these studies suggest that NRX-101 could become a new standard of care for bipolar depression, addressing a significant patient population in the US and globally.

NRx Pharmaceuticals is also developing NRX-101 for other potential applications, including chronic pain and complicated urinary tract infections. Additionally, the company plans to submit a New Drug Application for HTX-100 (IV ketamine) for the treatment of suicidal depression, based on results from clinical trials in collaboration with the US National Institutes of Health and French health authorities.

The findings from the NRX-101 trial could pave the way for future studies and potential regulatory approval, offering a new, effective treatment option for individuals suffering from bipolar depression and its associated complications.