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A Phase 2, Multicenter, Randomized, Double-blind, Placebo- and Active-controlled Trial of Brexpiprazole (1 - 3 mg/Day) as Monotherapy or as Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder

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A Phase 2, Multicenter, Randomized, Double-blind, Placebo- and Active-controlled Trial of Brexpiprazole (1 - 3 mg/Day) as Monotherapy or as Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 26 Jun 2024

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At a glance

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

    • Most Recent Events

    • 25 Jun 2024 According to Otsuka Pharmaceutical Media Release, based on results from Trial 061 (Phase II), 071 (Phase III) and Trial 072 (Phase III) was a fixed dose trial, the U.S. Food and Drug Administration (FDA) has determined that the supplemental New Drug Application (sNDA) for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD) is sufficiently complete to permit a substantive review. The FDA has assigned PDFU date February 8, 2025.
    • 28 May 2024 According to Otsuka Pharmaceutical Media Release, based on the trial data, Otsuka and Lundbeck submitted a supplemental New Drug Application (sNDA) in April to the U.S. Food and Drug Administration (FDA) for brexpiprazole in combination with sertraline for the treatment of adults living with PTSD.
    • 28 May 2024 According to Otsuka Pharmaceutical Media Release, data from the study were presented at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting in Miami.
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