On Oct. 17, 2024, Avadel Prescription drugs introduced the FDA authorised its supplemental new drug software for Lumryz for the therapy of cataplexy or extreme daytime sleepiness (EDS) in sufferers 7 years of age and older with narcolepsy.
About Lumryz
Lumryz is the one FDA-approved once-at-bedtime extended-release sodium oxybate therapy for cataplexy or EDS in sufferers 7 years of age and older with narcolepsy.
A substitute for twice-nightly oxybate drugs, Lumryz’s lowered dosing frequency avoids the necessity for sufferers to come up at night time, which can promote a extra pure sleep-wake cycle.
Lumryz was first authorised by the FDA in Could 2023 for the therapy of cataplexy or EDS in grownup sufferers with narcolepsy. The FDA approval of Lumryz was supported by outcomes from REST-ON, a randomized, double-blind, placebo-controlled, pivotal Part 3 trial in adults with narcolepsy.
The FDA granted orphan drug exclusivity in pediatric sufferers with narcolepsy aged 7 years and older via Oct. 2031.
About narcolepsy
Narcolepsy, a lifelong neurological dysfunction, disrupts regular sleep-wake cycles, inflicting sufferers to really feel overwhelmingly drained or expertise sudden episodes of muscle weak point referred to as cataplexy. With a prevalence of about one in 2,000 folks, this often-undiagnosed situation can considerably affect every day actions, similar to consuming, strolling and driving, highlighting the significance of recognizing and managing its signs.
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