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.