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A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multi-Dose Efficacy and Safety Study of Staccato Loxapine for Inhalation in Schizophrenic Patients With Agitation

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Trial Profile

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multi-Dose Efficacy and Safety Study of Staccato Loxapine for Inhalation in Schizophrenic Patients With Agitation

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Jul 2017

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At a glance

  • Drugs Loxapine (Primary)
  • Indications Agitation; Schizophrenia
  • Focus Registrational; Therapeutic Use
  • Sponsors Alexza Pharmaceuticals

    • Most Recent Events

    • 10 Oct 2016 According to Alexza Pharmaceuticals media release, US FDA approval of ADASUVE was based on clinical efficacy data of this and another pivotal trial.
    • 14 Dec 2012 The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion for Staccato loxapine based on results from this and the other pivotal trial as reported in an Alexza Pharmaceuticals media release.
    • 24 Jan 2011 Results of this trial published in the British Journal of Psychiatry, according to an Alexza Pharmaceuticals media release.

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