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Jennifer Gudeman, PharmD, Vice President of Medical and Clinical Affairs at Avadel Pharmaceuticals, discusses the post hoc analyses of data from the REST-ON clinical trial of FT218, an investigational treatment for narcolepsy
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Narcolepsy is a rare neurological disorder characterized by excessive sleepiness during the day, often with periods of brief involuntary sleep and/or cataplexy.
As Dr. Gudeman explains, FT218 is a long-acting form of sodium oxybate. A quick-release form of sodium oxybate was FDA approved in 2002 but, due to a short half-life, had to be taken twice a night. With FT218, the long-acting nature allows it to be taken once before bed.
The REST-ON study was a double-blind, randomized, placebo-controlled phase 3 trial assessing the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy.