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
Phase of Trial: Phase II/III
Latest Information Update: 11 Nov 2019
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At a glance
- Drugs Sodium oxybate (Primary)
- Indications Cataplexy; Narcolepsy
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms EXPRESS
- Sponsors Jazz Pharmaceuticals Inc
- 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.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History