AVDL - Avadel presents new clinical data from Phase 3 REST-ON trial of FT218 in narcolepsy

Avadel Pharmaceuticals ([[AVDL]]) announces new post hoc analyses of data from Phase 3 REST-ON trial of FT218. FT218 is currently under FDA review with PDUFA target date of October 15, 2021. Highlights from the poster presentations are outlined below. Efficacy of FT218 by Narcolepsy Subtype:FT218 demonstrated statistically significant improvement in excessive daytime sleepiness ((EDS)) at all evaluated doses in patients with narcolepsy subtypes 1 (NT1, with cataplexy) and 2 (NT2, without cataplexy) compared to placebo.The least squares ((LS)) mean difference in mean sleep latency (in minutes) on MWT between FT218 and placebo was 6.0 for 9 g (week 13), 7.0 for 7.5 g (week 8), and 4.9 for 6 g (week 3) in NT1 patients (all p<0.001), and 6.3 for 9 g (P<0.05), 4.0 for 7.5 g (P=NS), and 5.3 for 6 g (P<0.05) in NT2 patients.A significantly greater percentage of patients with NT1 receiving FT218 were rated as much or

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Avadel presents new clinical data from Phase 3 REST-ON trial of FT218 in narcolepsy