A Phase III, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Xyrem in Subjects With Fibromyalgia.

Trial Profile

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Xyrem in Subjects With Fibromyalgia.

Completed
Phase of Trial: Phase III

Latest Information Update: 03 Jun 2015

At a glance

  • Drugs Sodium oxybate (Primary)
  • Indications Fibromyalgia
  • Focus Registrational; Therapeutic Use
  • Sponsors Jazz Pharmaceuticals Inc
  • Most Recent Events

    • 06 May 2010 Results presented at 29th Annual Scientific Meeting of the American Pain Society.
    • 14 Apr 2010 Results presented at 62nd Annual Meeting of the American Academy of Neurology 2010.
    • 16 Dec 2009 According to a Jazz Pharmaceuticals media release, a New Drug Application has been submitted to the US FDA based on results from this and another pivotal trial (trial profile 700020839).
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