Phase III REST-ON trial supports benefit of Avadel's FT218 in narcolepsy

Ireland-incorporated Avadel Pharmaceuticals (Nasdaq: AVDL) has announced new post hoc analyses of data from the completed pivotal Phase III REST-ON clinical trial of FT218, at SLEEP 2021, the 35th Annual Meeting of the Associated Professional Sleep Societies (APSS), a joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society.

FT218 is currently under review at the US Food and Drug Administration, with a Prescription Drug User Fee Act (PDUFA) target date of October 15, 2021.

If approved, FT218 will be the first and only oxybate medication intended to be taken just once at bedtime, offering patients a new, more intuitive approach to obtaining safe, uninterrupted sleep throughout the night.