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A Double-blind, Randomized, Placebo Controlled, Two Arm Multi-center Study to Assess the Efficacy and Safety of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects With Narcolepsy

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Trial Profile

A Double-blind, Randomized, Placebo Controlled, Two Arm Multi-center Study to Assess the Efficacy and Safety of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects With Narcolepsy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Mar 2025

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At a glance

  • Drugs Sodium oxybate (Primary)
  • Indications Cataplexy; Narcolepsy
  • Focus Registrational; Therapeutic Use
  • Acronyms REST-On
  • Sponsors Avadel Pharmaceuticals; Flamel Technologies

Most Recent Events

  • 31 Oct 2024 According to an Avadel Pharmaceuticals media release, the U.S. District Court for the District of Columbia ruled in favor of the Food and Drug Administration in a suit brought by Jazz Pharmaceuticals Inc.under the Administrative Procedure Act regarding the FDA's approval of LUMRYZ for cataplexy or excessive daytime sleepiness in adults with narcolepsy.
  • 17 Oct 2024 According to an Avadel Pharmaceuticals media release, based on results from this trial U.S. Food & Drug Administration (FDA) has approved supplemental new drug application (sNDA) for LUMRYZ for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy.
  • 20 Aug 2024 According to an Avadel Pharmaceuticals media release, company announced the publication of results of a post-hoc analysis from this trial.

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