Avadel Pharmaceuticals completes enrollment in Phase 3 REVITALYZ trial

Avadel Pharmaceuticals (AVDL) announced the completion of patient enrollment in REVITALYZ, a Phase 3 trial evaluating LUMRYZTM extended-release oral suspension as a potential treatment for idiopathic hypersomnia. The primary objective of REVITALYZ is to demonstrate reduction in daytime sleepiness as measured by the primary endpoint, change in total score on the Epworth Sleepiness Scale at Week 14. Secondary endpoints will evaluate the effect of LUMRYZ on additional efficacy parameters including patient and clinician impression of change, idiopathic hypersomnia severity, and a measure of the functional outcomes of sleep.