A Multi-Center Randomized Double-Blind Placebo-Controlled Multi-Dose Efficacy and Safety Study of Staccato Loxapine for Inhalation in Patients With Bipolar I Disorder and Acute Agitation

Trial Profile

A Multi-Center Randomized Double-Blind Placebo-Controlled Multi-Dose Efficacy and Safety Study of Staccato Loxapine for Inhalation in Patients With Bipolar I Disorder and Acute Agitation

Completed
Phase of Trial: Phase III

Latest Information Update: 28 Jul 2017

At a glance

  • Drugs Loxapine (Primary)
  • Indications Agitation; Bipolar I disorders
  • 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.
    • 01 Sep 2010 Results have been presented at the European College of Neuropsychopharmacology Congress.
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