On June 5, 2025, Avadel Prescribed drugs introduced that the FDA granted orphan drug designation to Lumryz, its extended-release sodium oxybate treatment, for the therapy of idiopathic hypersomnia (IH). The FDA’s orphan drug designation gives incentives for medication and biologics for the therapy of uncommon ailments.
About Lumryz
Lumryz is a once-at-bedtime sodium oxybate treatment that provides a substitute for twice-nightly dosing. Its decreased dosing frequency eliminates the necessity for sufferers to wake through the evening.
The FDA permitted Lumryz in 2023 for the therapy of cataplexy or extreme daytime sleepiness (EDS) in adults with narcolepsy. In 2024, the approval was expanded to incorporate pediatric sufferers ages 7 and older with narcolepsy.
Lumryz is presently being studied for the therapy of IH within the REVITALYZ trial, a double-blind, placebo-controlled, randomized withdrawal, multicenter Part 3 research evaluating the efficacy and security of once-at-bedtime dosing. The trial is anticipated to conclude by the tip of 2025.
In line with the corporate’s press launch, Lumryz acquired orphan drug designation primarily based on the speculation that it might provide a significant contribution to affected person care via its once-nightly dosing, probably making it clinically superior to present therapies for IH.
Presently, Lumryz is permitted just for the therapy of cataplexy or EDS in sufferers ages 7 and older with narcolepsy.
About idiopathic hypersomnia
IH is a uncommon sleep problem characterised by extreme daytime sleepiness regardless of regular nighttime sleep period and high quality. People with IH might expertise issue waking up, exhibit confusion or a “sleep drunkenness” state upon awakening, and will discover their extended daytime naps to be unrefreshing, posing potential dangers in actions requiring alertness, equivalent to driving or working equipment.
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