Avadel Pharmaceuticals has dosed the first subject in the Phase III REVITALYZ clinical trial of LUMRYZ for the treatment of idiopathic hypersomnia (IH).
This multicentre, double-blind, placebo-controlled, randomised withdrawal clinical study is focused on evaluating the efficacy and safety of LUMRYZ.
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It aims to enrol approximately 150 adults with IH and includes an open label extension portion.
The trial is open to participants both switching from immediate-release oxybates and those not currently on oxybate therapy.
The primary goal of the study is to demonstrate a decline in daytime sleepiness, with the primary endpoint being the change in the total score of the Epworth Sleepiness Scale (ESS) at Week 14.
Secondary endpoints will assess LUMRYZ’s impact on additional efficacy parameters, including patient and clinician impression of change, IH severity, and functional outcomes of sleep.
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By GlobalDataLUMRYZ is an extended-release oral suspension of sodium oxybate. It received FDA approval in May 2023 as a once-at-bedtime treatment for cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.
The approval was based on the REST-ON trial, a pivotal Phase III study which showed significant improvements in EDS, clinicians’ overall assessment of patients’ functioning (CGI-I), and cataplexy attacks.
The FDA granted LUMRYZ seven years of orphan drug exclusivity for the treatment of cataplexy or EDS in adults with narcolepsy, recognising its clinical superiority over existing twice-nightly oxybate treatments.
Avadel Pharmaceuticals medical and clinical affairs senior vice-president Jennifer Gudeman said: “Dosing the first patient in REVITALYZ is an important milestone for the IH community, which has been vocal in the need for more treatment options, particularly an extended-release form of oxybate that would ideally provide full nocturnal drug exposure in a single, once-at-bedtime dose.
“We are committed to advancing this study and are emboldened by the excitement of experienced clinical trial sites’ participation, which reflects the critical unmet need in the current therapeutic landscape.”
