Avadel Pharmaceuticals has secured a significant victory as the U.S. District Court for the District of Columbia upheld the FDA's approval of LUMRYZ (sodium oxybate) for extended-release oral suspension. This decision, made on October 30, 2024, dismisses a suit brought by Jazz Pharmaceuticals Inc. challenging the FDA's decision to grant LUMRYZ approval and Orphan Drug Exclusivity. The court supported the FDA’s finding that LUMRYZ demonstrates clinical superiority over existing twice-nightly oxybate treatments for cataplexy and excessive daytime sleepiness (EDS) in adults with narcolepsy.
The legal challenge arose after the FDA's final approval and grant of Orphan Drug Exclusivity to LUMRYZ in May 2023. Jazz Pharmaceuticals contended that the approval was inconsistent with the Orphan Drug Act. Avadel CNS Pharmaceuticals intervened to defend the FDA’s position, successfully arguing for the upholding of LUMRYZ's approval.
Clinical Significance of LUMRYZ
LUMRYZ, approved by the FDA on May 1, 2023, is the first and only once-at-bedtime treatment for cataplexy or EDS in adult narcolepsy patients. On October 16, 2024, its approval was extended to include pediatric patients aged 7 years and older. This unique dosing regimen represents a significant advancement in patient care, minimizing sleep fragmentation and disruption compared to twice-nightly alternatives.
The FDA's approval was based on the positive results from the REST-ON Phase 3 trial, a randomized, double-blind, placebo-controlled study involving adult narcolepsy patients. The trial demonstrated statistically significant and clinically meaningful improvements across all three co-primary endpoints: EDS (measured by the Maintenance of Wakefulness Test), clinician’s overall assessment of patient functioning (CGI-I), and cataplexy attacks. These benefits were observed across all three evaluated doses of LUMRYZ compared to placebo.
Market Impact and Future Prospects
"We are pleased with the Court’s ruling in favor of the FDA’s clinical superiority determination for LUMRYZ... With the Court’s decision, LUMRYZ will continue to be available to the narcolepsy community and retain its Orphan Drug Exclusivity," stated Greg Divis, Chief Executive Officer at Avadel Pharmaceuticals. He further emphasized that the ruling solidifies LUMRYZ’s unique dosing schedule as a major contribution to patient care, enabling the company to continue its commercial launch and expand its reach within the narcolepsy community.
With the court's decision, Avadel is poised to further penetrate the narcolepsy market, offering a convenient once-at-bedtime option that improves adherence and quality of life for patients. The company will continue to focus on expanding LUMRYZ's availability and educating healthcare professionals and patients about its benefits.
