A US District Court has affirmed the FDA's approval of Avadel Pharmaceuticals' Lumryz (sodium oxybate) for the treatment of cataplexy or excessive daytime sleepiness in adults and pediatric patients (7 years and older) with narcolepsy, following a legal challenge by Jazz Pharmaceuticals. The court ruling supports the FDA's determination that Lumryz offers a clinically superior benefit over Jazz's twice-nightly oxybate products, particularly due to its once-at-bedtime administration. This decision allows Avadel to maintain its orphan drug exclusivity and continue its commercial launch of Lumryz.
Legal Challenge and Court's Decision
Jazz Pharmaceuticals filed a complaint against the FDA after Lumryz received final approval and Orphan Drug Exclusivity in May 2023, arguing that the approval was inconsistent with the Orphan Drug Act. Avadel Pharmaceuticals intervened to defend the FDA's decision. The court ultimately ruled in favor of the FDA, supporting the agency's assessment of Lumryz's clinical superiority.
Greg Divis, chief executive officer at Avadel Pharmaceuticals, stated, "We are pleased with the court’s ruling in favor of the FDA’s clinical superiority determination for Lumryz in conjunction with final approval for use in adults with narcolepsy... Yesterday’s ruling further solidifies Lumryz’s unique once-at-bedtime dosing schedule as a major contribution to patient care and enables us to continue executing on our commercial launch and expanding Lumryz’s reach within the narcolepsy community."
Clinical Basis for Approval
Lumryz's approval was based on the results of the REST-ON trial, a Phase 3 randomized, double-blind, placebo-controlled study in adult narcolepsy patients. The trial demonstrated statistically significant and clinically meaningful improvements in excessive daytime sleepiness, clinician’s overall assessment of patient functioning, and cataplexy attacks across all three evaluated doses compared to placebo. These findings supported the FDA's decision to grant orphan drug exclusivity to Lumryz, recognizing its clinical advantages over existing oxybate treatments.
Orphan Drug Exclusivity
The FDA granted seven years of Orphan Drug Exclusivity to Lumryz for the treatment of cataplexy or excessive daytime sleepiness in adult and pediatric narcolepsy patients, citing its clinical superiority over currently available oxybate treatments. This exclusivity provides Avadel with a period of market protection, fostering further investment in the drug's development and commercialization.
