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.
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Date Created: April 28th, 2020
Last Updated: April 28th, 2020