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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December 19, 2025 15:10 ET U.S. inflation data and interest rate decisions by major central banks were the highlights of this busy week for economics news flow. Employment data and survey results on the housing markets also gained attention in the U.S. In Europe, the European Central Bank and Bank of England announced their policy decisions and macroeconomic projections.