AVDL - Avadel posts new efficacy and safety data for lead candidate in narcolepsy

On Friday, the clinical-stage pharma company, Avadel Pharmaceuticals (NASDAQ:AVDL) announced additional data for the company’s lead asset FT218 from a pivotal late-stage trial and an open-label study. FT218 is a formulation of sodium oxybate designed as a once-nightly regimen for excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy. The announcement included new post-hoc data from the completed pivotal Phase 3 REST-ON clinical trial and interim data from the ongoing RESTORE open-label study, the company said. Per REST-ON data, those who took FT218 showed an improvement in subjective measures of daytime sleepiness, sleep quality, and the refreshing nature of sleep. The 4.5-g starting dose was found to cause an improvement as early as week 1, while there was even a greater improvement after starting the 6-g dose, compared to placebo. According to data from the RESTORE study, FT218 was found to be well tolerated with no new safety signals

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Avadel posts new efficacy and safety data for lead candidate in narcolepsy