Adjust Font Sizing:

Avadel Pharmaceuticals Announces Results from its Phase 3 Trial of Once-Nightly FT218

April 28th, 2020

Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced positive topline data from its pivotal Phase 3 REST-ON trial assessing the safety and efficacy of FT218, an investigational, once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy.

The primary analysis of investigational, once-nightly FT218 at 9 g demonstrated highly statistically significant (p<0.001), and clinically meaningful improvement across all three co-primary endpoints compared to placebo:

  • Clinically significant improvement in wakefulness, as measured by improvement in MWT
  • Significant improvement in Clinical Global Impression-Improvement (CGI-I)
  • Significant improvement in cataplexy (measured by mean weekly cataplexy events)
  • Once-nightly FT218 at 9 g was generally well-tolerated with commonly known sodium oxybate adverse reactions occurring at low rates
  • Once-nightly FT218 at the 7.5 g and 6 g dose levels achieved highly statistically significant (p<0.001), clinically meaningful improvements across all three co-primary endpoints compared to placebo.

Read the full press release here.

# # #
Date Created: April 28th, 2020
Last Updated: December 21st, 2023