On Oct. 17, 2024, Avadel Pharmaceuticals announced the FDA approved its supplemental new drug application for Lumryz for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
About Lumryz
Lumryz is the only FDA-approved once-at-bedtime extended-release sodium oxybate treatment for cataplexy or EDS in patients 7 years of age and older with narcolepsy.
An alternative to twice-nightly oxybate medications, Lumryz’s reduced dosing frequency avoids the need for patients to arise at night, which may promote a more natural sleep-wake cycle.
Lumryz was first approved by the FDA in May 2023 for the treatment of cataplexy or EDS in adult patients with narcolepsy. The FDA approval of Lumryz was supported by results from REST-ON, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial in adults with narcolepsy.
The FDA granted orphan drug exclusivity in pediatric patients with narcolepsy aged 7 years and older through Oct. 2031.
About narcolepsy
Narcolepsy, a lifelong neurological disorder, disrupts normal sleep-wake cycles, causing patients to feel overwhelmingly tired or experience sudden episodes of muscle weakness known as cataplexy. With a prevalence of about one in 2,000 people, this often-undiagnosed condition can significantly impact daily activities, such as eating, walking and driving, highlighting the importance of recognizing and managing its symptoms.
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