FDA accepts for review New Drug Application (NDA) for investigational, once-nightly formulation of sodium oxybate (FT218) for treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy

This formulation utilises Avadel’s MicroPump™ controlled-release technology. If approved, it will be the first and only once-nightly oxybate medication, an advance on the twice-nightly regimen in current use. NDA submission is supported by data from Phase 3 REST-ON study.

SPS commentary:

In the UK, sodium oxybate is available as an oral solution for the treatment of narcolepsy with cataplexy in adult patients, adolescents and children from the age of 7 years. The recommended starting dose is 4.5 g/day divided into two equal doses of 2.25 g.

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