The brain has neuronal systems that respond to skin temperature. In narcolepsy, these systems act as a switch, determining whether the brain enters REM sleep or triggers muscle paralysis while the person is awake.
For those living with narcolepsy or are pre-diagnosis, mischaracterizations can result in stigma and contribute to the extended average delay in diagnosis.
The US Food and Drug Administration has granted tentative approval to LUMRYZ, also known as FT218, by Avadel Pharmaceuticals plc.
During the second quarter, Jazz Pharmaceuticals registered a 39% year-over-year growth in net product sales of its low-sodium Xywav.
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Avadel aims to expand the potential of Lumryz with a supplemental New Drug Application filing planned in the second half of 2023 for Lumryz in the pediatric narcolepsy population.
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In a phase 2 trial involving patients with narcolepsy type 1, TAK-994 demonstrated statistically significant improvements in wakefulness and reduced cataplexy rates compared to placebo but was associated with hepatotoxic effects.
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Sodium oxybate oral solution is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness in patients aged 7 and older with narcolepsy.
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The approval makes pitolisant the first and only treatment drug approved in mainland China for narcolepsy.
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After receiving FDA approval last month, Lumryz, a once-nightly formulation of sodium oxybate, is now commercially available for adults with narcolepsy.
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Jazz Pharmaceuticals is presenting seven abstracts featuring new data from across its sleep medicine portfolio, encompassing idiopathic hypersomnia and narcolepsy.
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The AMAZE Program will encompass two double-blind phase 3 trials investigating Quilience versus placebo in adult patients with narcolepsy, commencing this summer at multiple US sites.
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The company reported business updates for the quarter ending March 31, noting continued momentum in its commercial business for Wakix, as well as in the advancement of its clinical development programs for pitolisant for the treatment of idiopathic hypersomnia.
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The European Medicines Agency approved Wakix for the treatment of narcolepsy in children over 6 years of age, with or without cataplexy.
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If approved, Avadel expects once-at-bedtime Lumryz to be the treatment of choice for patients with narcolepsy-related excessive daytime sleepiness or cataplexy.
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Emerging study results look at potential changes in daytime sleepiness and cataplexy in narcolepsy patients treated with Quilience.
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A SLEEP 2022 poster presents a post-hoc analysis of pooled data from patients in WAKIX pivotal clinical trials who had a high burden of narcolepsy.
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Jazz announced on Monday that the U.S. Food and Drug Administration granted them Orphan Drug Exclusivity for the medication Xywav for the treatment of idiopathic hypersomnia.
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A new data analysis evaluates time to onset of response to pitolisant for excessive daytime sleepiness and cataplexy in narcolepsy patients.
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