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A Phase 3, Long-Term, Open-Label Study of Safety and Tolerability of Cariprazine as Adjunctive Therapy in Major Depressive Disorder

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Trial Profile

A Phase 3, Long-Term, Open-Label Study of Safety and Tolerability of Cariprazine as Adjunctive Therapy in Major Depressive Disorder

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Dec 2022

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At a glance

  • Drugs Cariprazine (Primary) ; Antidepressants
  • Indications Major depressive disorder
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Allergan; Forest Laboratories

    • Most Recent Events

    • 16 Dec 2022 According to an AbbVie media release, the U.S. Food and Drug Administration (FDA) has approved VRAYLAR (cariprazine) as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults.
    • 23 May 2022 According to an AbbVie media release, FDA's decision on sNDA is expected by year-end.
    • 22 Feb 2022 According to AbbVie media release, the company has submitted a supplemental New Drug Application (sNDA) for cariprazine (VRAYLAR) to the U.S. Food and Drug Administration (FDA) for the adjunctive treatment of major depressive disorder (MDD) in patients who are receiving ongoing antidepressant therapy. The submission is supported by results from previously announced clinical trials (NCT03738215, NCT01469377, NCT01838876

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