Avadel Pharmaceuticals plc, a biopharmaceutical company focused on transforming medicines to transform lives, announced that, on Friday, June 27, 2025, the U.S. Court of Appeals for the District of Columbia Circuit (the “Appeals Court”) affirmed a prior decision of the U.S. District Court for the District of Columbia (the “District Court”) in favor of the U.S. Food and Drug Administration (“FDA”) in a suit brought by Jazz Pharmaceuticals Inc. (“Jazz”) regarding the FDA’s approval of LUMRYZTM, the first and only once-at-bedtime oxybate treatment for cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy.
“The unanimous decision by the Appeals Court panel upholding the FDA’s approval of LUMRYZ underscores the importance of its innovative formulation and validates its benefits for people with narcolepsy,” said Greg Divis, Chief Executive Officer at Avadel Pharmaceuticals. “The ruling affirms the FDA’s decision, which the Appeals Court noted was undisputed, that LUMRYZ’s once-at-bedtime dosing is clinically superior to all first generation, immediate-release oxybates and provides a major contribution to patient care.”
“Importantly, with this ruling, LUMRYZ will continue to be available for narcolepsy patients to consistently experience the benefits of a full, therapeutic, once-at-bedtime dose of oxybate therapy offering the potential for an uninterrupted night’s sleep. We will continue advancing our commercial strategy to ultimately transform the sleep treatment paradigm for the narcolepsy community and increase the number of patients well beyond the thousands currently treated with LUMRYZ,” continued Mr. Divis.
Following the District Court’s ruling in favor of the FDA and Avadel in October 2024, which granted the FDA’s Motions for Summary Judgment with respect to Jazz’s complaint and denied Jazz’s Motion for Summary Judgment, Jazz filed a notice of appeal to the Appeals Court. On June 27, 2025, the Appeals Court, in a unanimous panel decision, affirmed the District Court’s ruling and upheld the FDA’s approval of LUMRYZ.
Source: GlobeNewswire
