Avadel (AVDL) Soars On REST-ON Trial Results

(RTTNews) - Avadel Pharmaceuticals plc's (AVDL) pivotal phase III trial evaluating FT218 for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy has met its three co-primary efficacy endpoints at all three doses.

In the study, dubbed REST-ON, all three dose levels of once-nightly FT218 - 9 g, 7.5 g, and 6 g - demonstrated a statistically significant and clinically meaningful improvement on the measures of the two prominent symptoms of narcolepsy, as well as an improvement in overall functioning compared to placebo, noted the Company.

FT218 is a once-nightly formulation of sodium oxybate. If approved, FT218 will compete with Jazz Pharma's (JAZZ) Xyrem (sodium oxybate), which has twice nightly dosing. Xyrem recorded annual sales of $1.64 billion in 2019.

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