FDA Grants Final Approval for Treatment of Cataplexy in Adults With Narcolepsy

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The US Food and Drug Administration (FDA) has granted final approval to Lumryz (sodium oxybate) for the treatment of cataplexy and excessive daytime sleepiness in adults who have narcolepsy.

Lumryz is an extended-release formulation of sodium oxybate that is now the first and only FDA-approved treatment for this patient population that is indicated to be taken only once at bedtime. The FDA based its decision to grant final approval to Lumryz on positive results from the Phase 3 REST-ON clinical study, which was completed in March 2020. In the study’s phase 3 trial, the drug taken once at bedtime showed statistically significant (p<0.001), clinically meaningful improvement across all primary endpoints in comparison to placebo when evaluated at 6, 7.5, and 9 grams. Lumryz was developed by Avadel Pharmaceuticals.¹

“Today’s landmark approval and receipt of Orphan Drug Exclusivity represents a major milestone for both Avadel and people living with narcolepsy,” said Greg Divis, chief executive officer of Avadel, in a press release. 

“As we have heard from key stakeholders, previously approved narcolepsy therapies have the potential to disrupt sleep by either causing insomnia or through forced awakening during the middle of the night for their crucial second dose. LUMRYZ can now offer people with narcolepsy the opportunity for an uninterrupted night sleep while receiving the full benefit of their prescribed treatment in 1 single bedtime dose that addresses their symptoms of narcolepsy.”

Reference

1. Avadel Pharmaceuticals announces final FDA approval of LUMRYZ (sodium oxybate) for extended-release oral suspension as the first and only once-at-bedtime oxybate for cataplexy or excessive daytime sleepiness in adults with narcolepsy. Benzinga. News release. May 1, 2023. Accessed May 1, 2023. https://www.benzinga.com/pressreleases/23/05/g32128251/avadel-pharmaceuticals-announces-final-fda-approval-of-lumryz-sodium-oxybate-for-extended-release-