DUBLIN – Avadel Pharmaceuticals plc (NASDAQ:AVDL), a biopharmaceutical company, today announced a mixed outcome in its recent patent litigation against Jazz Pharmaceuticals (NASDAQ:JAZZ) Inc.
A jury from the United States District Court for the District of Delaware ruled partially in favor of Avadel regarding one of the contested patents for its narcolepsy treatment, LUMRYZ™. However, the decision was not entirely favorable, as the jury also ruled against Avadel concerning an additional contested patent.
The company expressed its intent to "vigorously defend its position" by exploring all available options, including an appeal to overturn the unfavorable portion of the jury's decision after the Court's final decision is entered. Despite the setback, Avadel remains confident that this legal matter will not affect the ongoing commercial launch or the potential of LUMRYZ™ to aid adults living with narcolepsy.
LUMRYZ™, an extended-release sodium oxybate oral suspension, received approval from the U.S. Food & Drug Administration on May 1, 2023. It is the first once-at-bedtime treatment for cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.
The approval was based on the REST-ON Phase 3 trial, which demonstrated significant improvements in the treatment of narcolepsy symptoms. Additionally, LUMRYZ™ has been granted seven years of Orphan Drug Exclusivity by the FDA due to its clinical superiority over existing treatments, offering a once-nightly dosing regimen as opposed to the standard twice-nightly regimen.
As a company focused on innovative solutions for medication development, Avadel continues to prioritize the transformation of patient care. The press release statement from Avadel Pharmaceuticals plc serves as the basis for this report.
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