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Abstract Clinical trials in early untreated Parkinson’s Disease risk confounding due to treatment initiation. Milder clinical features, functional preservation, and slow progression raise questions as to how meaningful benefit can be demonstrated before treatment begins. Time-to-event (TTE) outcomes may be valuable to detect benefit before treatment.
Highlights • FT218 is an investigational once-nightly sodium oxybate (SO) for the treatment of narcolepsy. • FT218 pharmacokinetics (PK) in healthy adults support once-nightly dosing. • Overall exposure, variability, and safety were similar to twice-nighty SO. • Cmax, C8h, and food effect were lower, with dose proportionality. • FT218 PK suggest potential clinical therapeutic benefits over twice-nightly SO.
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