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Avadel Pharmaceuticals plc (NASDAQ:AVDL), today issued a statement in response to a jury ruling from the United States District Court for the District of Delaware ("Court") in a patent suit brought by Jazz Pharmaceuticals Inc. regarding LUMRYZ™.
Avadel is pleased with the jury's decision ruling in favor of Avadel with respect to one of the contested patents. As it relates to the jury's decision against Avadel regarding the additional contested patent, the company is disappointed in the outcome. Avadel will vigorously defend its position with the pursuit of all options, including an appeal, to overturn the unfavorable aspect of the jury's decision upon final entry of the decision by the Court.
Avadel does not expect the jury's decision to impact the ongoing commercial launch or potential for LUMRYZ™ to transform the lives of people living with narcolepsy.
About LUMRYZ™ (sodium oxybate) for extended-release oral suspension
LUMRYZ, is an extended-release sodium oxybate medication approved by the FDA on May 1, 2023, as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.
The FDA approval of LUMRYZ was supported by results from REST-ON, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial in adults with narcolepsy. LUMRYZ demonstrated statistically significant and clinically meaningful improvements in the three co-primary endpoints: EDS, clinicians' overall assessment of patients' functioning (CGI-I) and cataplexy attacks, for all three evaluated doses when compared to placebo.
With its approval, the FDA also granted seven years of Orphan Drug Exclusivity to LUMRYZ for the treatment of cataplexy or EDS in adults with narcolepsy due to a finding of clinical superiority of LUMRYZ relative to currently available oxybate treatments. In particular, the FDA found that LUMRYZ makes a major contribution to patient care over currently available, twice-nightly oxybate products by providing a once-nightly dosing regimen that avoids nocturnal arousal to take a second dose.
