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# Avadel Wins Expanded Label for Lumryz
- URL: https://www.fdaweb.com/avadel-wins-expanded-label-for-lumryz/
- Published: 2024-10-18T12:00:00.000Z
- Updated: 2026-09-14T14:44:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158013

FDA has approved an Avadel Pharmaceuticals supplemental NDA for Lumryz (sodium oxybate) for treating cataplexy or excessive daytime sleepiness (EDS) in patients seven years of age and older with narcolepsy. The drug was originally approved 5/2023 for the same indication but in adult patients.

Approval for the pediatric indication was based on data from REST-ON Phase 3 trial, that demonstrated Lumryz had statistically significant and clinically meaningful improvements in the three co-primary endpoints: EDS, clinicians’ overall assessment of patients’ functioning, and cataplexy attacks, for all three evaluated doses when compared to placebo, the company says.