Benzinga | Apr 19, 2021 07:05AM EDT

Avadel's Formulated Sodium Oxybate Shows Improved Sleepiness, Sleep Quality In Narcolepsy Patients

* Avadel Pharmaceuticals Plc (NASDAQ: AVDL) has announced the presentation of secondary endpoint data from the Phase 3 REST-ON trial evaluating FT218 once-nightly formulation of sodium oxybate (ON-SXB) for excessive daytime sleepiness and cataplexy in adults with narcolepsy.

* Narcolepsy is a chronic sleep disorder characterized by daytime drowsiness and sudden attacks of sleep. People with narcolepsy often find it challenging to stay awake for long periods, regardless of the circumstances.

* FT218 demonstrated significant sleep consolidation for the 6 g dose at Week 3, the 7.5 g dose at Week 8, and the 9 g dose at Week 13 compared to placebo.

* The study showed that the mean difference between FT218 and placebo for disturbed nocturnal sleep (shifts from deeper to lighter stages of sleep and wake) was statistically significant at all doses.

* The mean difference between FT218 and placebo for the number of arousals was --23.68 at 9 g, --19.41 at 7.5 g, and --11.29 at 6 g.

* FT218 was generally well-tolerated. It demonstrated significant improvement in Sleepiness Scale versus placebo at all doses tested, improved sleep quality and refreshing nature of sleep, and sleep paralysis compared to placebo.

* Price Action: AVDL shares closed 0.8% lower at $8.62 on Friday.