Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A Double-Blind, Placebo-Controlled, Randomized-Withdrawal, Multicenter Study of the Efficacy and Safety of Xyrem with an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects with Narcolepsy with Cataplexy

Trial Profile

A Double-Blind, Placebo-Controlled, Randomized-Withdrawal, Multicenter Study of the Efficacy and Safety of Xyrem with an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects with Narcolepsy with Cataplexy

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 11 Nov 2019

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Sodium oxybate (Primary)
  • Indications Cataplexy; Narcolepsy
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms EXPRESS
  • Sponsors Jazz Pharmaceuticals Inc
  • Most Recent Events

    • 26 Apr 2019 Status changed from active, no longer recruiting to completed.
    • 29 Oct 2018 According to a Jazz Pharmaceuticals plc Media Release, the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) on October 26, 2018, to revise labeling for Xyrem (sodium oxybate) oral solution, CIII, to include an indication to treat cataplexy or excessive daytime sleepiness (EDS) in patients with narcolepsy ages seven and older.
    • 07 Aug 2018 According to a Jazz Pharmaceuticals plc Media Release, In June 2018, the U.S. Food and Drug Administration (FDA) accepted for priority review the companys supplemental new drug application (sNDA) seeking revised labeling for Xyrem to include an indication to treat cataplexy and excessive daytime sleepiness in pediatric narcolepsy patients. The Prescription Drug User Fee Act goal date for an FDA decision is October 27, 2018.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top