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A Phase III trial of SLS-002 for Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD)

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Trial Profile

A Phase III trial of SLS-002 for Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD)

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 30 Jan 2024

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At a glance

  • Drugs Ketamine (Primary)
  • Indications Major depressive disorder; Suicidal ideation
  • Focus Registrational; Therapeutic Use
  • Sponsors Vyera Pharmaceuticals

    • Most Recent Events

    • 22 Jan 2024 According to a Seelos Therapeutics media release, in the meeting minutes, the FDA agreed that the primary endpoint in a Phase III trial could be the change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score at Day 16, rather than the 24-hour timepoint that was selected in the Phase II SLS-002-201 study. The key secondary endpoint could be the change from baseline at 24 hours on the suicidality scale.
    • 26 Feb 2020 According to a Seelos Therapeutics media release, the company looks forward to the Type C meeting with FDA in March for input and feedback on the proposed adaptive Phase III trial design for SLS-002 for Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD).
    • 28 Mar 2019 According to a Seelos Therapeutics media release, the company is planing for a post-Phase II meeting with the FDA to discuss trial design requirements for this pivotal study.

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