Avadel Pharma shares soar 22% premarket after FDA cuts sample size in trial of narcolepsy treatment
Avadel Pharmaceuticals PLC shares soared about 22% in premarket trade Monday, after the company said the U.S. Food and Drug Administration has agreed to reduce the sample size in a phase 3 trial of a treatment for narcolepsy. The company said it now expects full enrollment for the trial of once-nightly sodium oxybate, or FT218, to be completed by year-end. The lower sample size needed to demonstrate significance for excessive daytime sleepiness and cataplexy in narcolepsy patients will reduce the estimated time for the trial by up to 12 months. The study will now target 205 patients, down from 264 previously. Topline data is expected in the second quarter of 2020, up to a year ahead of earlier expectations. FT218 has been granted orphan drug designation by the FDA, meaning its path to approval has been accelerated. Shares have gained 31% in 2019, while the S&P 500 has gained 19%.
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