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
Phase of Trial: Phase III
Latest Information Update: 14 Apr 2018
At a glance
- Drugs Sodium oxybate (Primary)
- Indications Narcolepsy
- Focus Registrational; Therapeutic Use
- Acronyms Rest-On
- Sponsors Flamel Technologies
- 10 Jan 2018 According to an Avadel Pharmaceuticals media release, the company is looking forward to complete the trial this year 2018.
- 29 Dec 2017 According to an Avadel Pharmaceuticals media release, the company expects to file an NDA with the US FDA by the end of 2018.
- 30 Aug 2017 Planned primary completion date changed from 1 Jan 2018 to 1 Apr 2018.