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: 28 Sep 2017

At a glance

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

    • 28 Sep 2017 According to an Indivior media release, based on the data from this and other trial (see profile 247838), the company has submitted a New Drug Application (NDA) to the U.S. FDA to seek marketing approval for RBP-7000 in the ATRIGEL delivery system for the treatment of schizophrenia.
    • 30 Jan 2017 Results of exposure-response analysis for RBP-7000, published in the British Journal of Clinical Pharmacology.
    • 12 Mar 2016 Results (n=350) presented at the 117th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics.
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