A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of RBP-7000 as a Treatment in Subjects With Acute Schizophrenia Over 8 Weeks (2 Subcutaneous Doses)

Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of RBP-7000 as a Treatment in Subjects With Acute Schizophrenia Over 8 Weeks (2 Subcutaneous Doses)

Completed
Phase of Trial: Phase III

Latest Information Update: 27 Jul 2018

At a glance

  • Drugs Risperidone (Primary) ; Risperidone (Primary)
  • Indications Schizophrenia
  • Focus Registrational; Therapeutic Use
  • Sponsors Indivior; Reckitt Benckiser
  • Most Recent Events

    • 27 Jul 2018 According to Indivior, media release, the U.S. Food and Drug Administration (FDA) has approved PERSERIS the first once-monthly subcutaneous risperidone-containing, long-acting injectable (LAI) for the treatment of schizophrenia in adults.
    • 09 May 2018 Results assessing safety and efficacy from two phase III trials (NCT02109562 and NCT02203838) presented at the 171st Annual Meeting of the American Psychiatric Association
    • 12 Dec 2017 According to an Indivior media release,The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for RBP-7000, an investigational, once-monthly injectable risperidone in the ATRIGEL delivery system for the treatment of schizophrenia.The FDA has set a PDUFA (Prescription Drug User Fee Act) target action date of July 28, 2018.
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