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Secondary endpoint data for once-nightly FT218 further supports previously announced topline data demonstrating clinically meaningful results at 6 g, 7.5 g, and 9 g doses
DUBLIN, Ireland, April 17, 2021 (GLOBE NEWSWIRE) Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate (ON-SXB) for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy, today announced the presentation of positive secondary endpoint data at the 2021 American Academy of Neurology Annual (AAN) Meeting being held virtually from April 17-22, 2021. FT218 is currently under review at the U.S. Food and Drug Administration with a Prescription Drug User Fee Act (PDUFA) target date of October 15, 2021.
DublinIrelandUnited-statesAmericanJennifer-gudemanTom-mchughPatrick-burseyAvadel-micropumpMichaelj-thorpyTim-mccarthyLifesci-advisorsAvadel-pharmaceuticals