Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ)

Summary

This is a double-blind, placebo-controlled, randomized withdrawal, multicenter study of the efficacy and safety of FT218. FT218 drug product is a once-nightly formulation of sodium oxybate for extended-release oral suspension. The study will enroll subjects who are diagnosed with idiopathic hypersomnia. Subjects will be eligible to enroll regardless of current treatment with oxybate therapy or stimulants/alerting agents at study entry. The estimated total duration of study for each subject is approximately 18 weeks, including the Screening period.

Timeline

Start

2024-08-01

Primary completion

2026-03-25

Completion

2026-03-25

Outcome

Met primary endpoint

release “LUMRYZ met the study’s primary endpoint, demonstrating statistically significant improvements in excessive daytime sleepiness compared to placebo” alkermes.com ↗

Drugs

Indications