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A Randomized, Double-Blind Controlled Comparison of NRX-101 to Lurasidone for Adults With Bipolar Depression and Subacute Suicidal Ideation or Behavior

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Trial Profile

A Randomized, Double-Blind Controlled Comparison of NRX-101 to Lurasidone for Adults With Bipolar Depression and Subacute Suicidal Ideation or Behavior

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 28 Nov 2024

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At a glance

  • Drugs Cycloserine/lurasidone (Primary) ; Lurasidone
  • Indications Bipolar depression; Suicidal ideation
  • Focus Registrational; Therapeutic Use
  • Sponsors NeuroRX; NRx Pharmaceuticals

    • Most Recent Events

    • 25 Nov 2024 According to a NRx Pharmaceuticals media release, company developed training and monitoring methodology in this phase 2b/3 clinical trial of NRX-101 documents higher interrater reliability (IRR) on primary endpoint (MADRS depression scale) than previously reported industry standards Positive implications for conduct of future registration trials for NRX-101 and similar medications.
    • 14 Aug 2024 According to a NRx Pharmaceuticals media release, company plans to file a New Drug Application (NDA) for Accelerated Approval under Breakthrough Therapy Designation and Priority Review of NRX-101 in treatment of bipolar depression in people akathisia or suicidality, based on the Phase 2b/3 and STABIL-B data
    • 28 May 2024 Results published in the NRx Pharmaceuticals media release

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