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A Phase 3, Multicenter, Randomized, Double-blind Trial of Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder

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A Phase 3, Multicenter, Randomized, Double-blind Trial of Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Jan 2025

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At a glance

  • Drugs Brexpiprazole (Primary) ; Sertraline (Primary)
  • Indications Post-traumatic stress disorders
  • Focus Registrational; Therapeutic Use
  • Sponsors Otsuka Pharmaceutical Development & Commercialization

    • Most Recent Events

    • 10 Jan 2025 According to Otsuka Pharmaceutical Media Release, the Company announced that the FDA plans to host a Psychopharmacologic Drugs Advisory Committee (PDAC) meeting to seek input on issues related to the sNDA for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD). A final date for the meeting has yet to be set by the FDA, but it is currently anticipated to occur during the first half of 2025.
    • 20 Dec 2024 According to Otsuka Pharmaceutical Media Release, data from this study were published in the JAMA Psychiatry.
    • 18 Dec 2024 Results published in an Otsuka Pharmaceutical Development & Commercialization Media Release.

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