FDA Approves Lumryz for Narcolepsy

5 mei 2023

FDA Approves Lumryz for Narcolepsy

The U.S. Food & Drug Administration has approved Lumryz for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy. Lumryz is an extended-release formulation of sodium oxybate to be taken once at bedtime.

The approval was based on results from the REST-ON phase 3 trial, in which once-at-bedtime Lumryz led to significant and clinically meaningful improvement across the three coprimary end points of Maintenance of Wakefulness Test, Clinical Global Impression-Improvement, and mean weekly cataplexy attacks versus placebo for all three doses evaluated.

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FDA Approves Lumryz for Narcolepsy