Avadel Pharmaceuticals

FDA approves Avadel Pharmaceuticals’ Lumryz for pediatric narcolepsy, offering a once-nightly treatment. Lumryz, initially approved for adults, demonstrated significant improvements in a Phase III trial, with common adverse events occurring at low frequencies. This expansion addresses the challenges of middle-of-the-night dosing for pediatric patients.

On Oct. 17, 2024, Avadel Pharmaceuticals' Lumryz, the only FDA-approved once-at-bedtime extended-release sodium oxybate for narcolepsy patients aged 7+, received FDA approval for treating cataplexy or EDS. Lumryz, first approved in May 2023 for adults, offers a simpler dosing regimen, potentially improving sleep-wake cycles. Narcolepsy, affecting 1 in 2,000, disrupts daily life, underscoring the need for effective treatments.

FDA approves Avadel Pharmaceuticals’ LUMRYZ for pediatric narcolepsy patients aged 7+, offering a once-nightly treatment for cataplexy and excessive daytime sleepiness, with Orphan Drug Exclusivity until 2031.

The FDA approved sodium oxybate (Lumryz) for treating cataplexy or excessive daytime sleepiness in narcolepsy patients aged 7 and older. This extended-release oral suspension is taken once at bedtime, addressing adherence issues with twice-nightly regimens. The approval was supported by the phase 3 REST-ON trial, which showed significant improvements in sleep quality and reduced nocturnal arousals.

FDA approves sodium oxybate (Lumryz) for cataplexy or EDS in pediatric narcolepsy patients aged 7 and older, making it the only once-at-bedtime oxybate treatment. The drug has Orphan Drug Exclusivity until 2031 and is available under a restricted program due to potential for abuse.

Avadel Pharmaceuticals announces FDA approval of LUMRYZ for narcolepsy treatment in patients 7 years and older, offering a once-nightly option without middle-of-the-night dosing.

FDA approves sodium oxybate (LUMRYZ) for cataplexy and excessive daytime sleepiness in children aged ≥ 7 with narcolepsy, based on a double-blind study. This expands oxybate availability to pediatric patients, offering a single bedtime dose.

FDA approves Avadel Pharmaceuticals' sodium oxybate (Lumryz) for cataplexy or EDS in narcolepsy patients aged 7 and older, offering a once-nightly treatment option that reduces the need for middle-of-the-night dosing.

Avadel Pharmaceuticals' LUMRYZ, a once-at-bedtime oxybate treatment, is now FDA-approved for cataplexy or EDS in narcolepsy patients aged 7 and older, including pediatric patients, with Orphan Drug Exclusivity granted through October 2031.

Avadel Pharmaceuticals announces FDA approval of Lumryz for treating cataplexy or excessive daytime sleepiness in narcolepsy patients aged 7 and older.