A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Fixed-dose OPC-34712 in the Treatment of Adults With Acute Schizophrenia

Trial Profile

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Fixed-dose OPC-34712 in the Treatment of Adults With Acute Schizophrenia

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Jun 2018

At a glance

  • Drugs Brexpiprazole (Primary)
  • Indications Schizophrenia
  • Focus Registrational; Therapeutic Use
  • Acronyms BEACON
  • Sponsors Otsuka Pharmaceutical Development & Commercialization
  • Most Recent Events

    • 01 Jun 2018 According to a Lundbeck A/S media release, Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion on Rxulti (brexpiprazole) for the treatment of schizophrenia in adults. A final decision from the European Commission is expected within 67 days.
    • 22 Jun 2017 Results of a pooled analysis assessing short-term and long-term efficacy of brexpiprazole in patients from three randomised trials (NCT01396421, NCT01393613 and NCT01668797; n=1278) presented at the 13th World Congress of Biological Psychiatry
    • 23 Mar 2017 According to a Lundbeck media release,The European Medicines Agency (EMA) is expected to complete its review for a a Marketing Authorisation Application in second quarter of 2018.
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