Shares of Avadel Pharmaceuticals PLC (NASDAQ:AVDL) rose 4.7% following a key legal victory, as a U.S. appeals court unanimously upheld the FDA’s approval of LUMRYZ, the company’s once-nightly treatment for narcolepsy. The decision marks a significant step forward in Avadel’s efforts to solidify its presence in the sleep disorder treatment space.
The U.S. Court of Appeals for the District of Columbia Circuit ruled in favor of the FDA on Friday, affirming an earlier decision by a lower court in a lawsuit filed by Jazz Pharmaceuticals (NASDAQ:JAZZ) under the Administrative Procedure Act. The ruling enables LUMRYZ, the first and only FDA-approved oxybate formulation taken once at bedtime, to remain available to eligible patients.
“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, CEO of Avadel Pharmaceuticals.
Jazz initially filed suit against the FDA following LUMRYZ’s approval, challenging the agency’s decision. After losing in district court in October 2024, Jazz appealed the outcome. On June 27, the appellate panel fully sided with the FDA and Avadel, stating it was “undisputed” that LUMRYZ’s once-at-bedtime formulation offers clinically superior benefits compared to earlier, immediate-release oxybates and delivers a major contribution to patient care.
Approved for patients ages 7 and up with narcolepsy experiencing cataplexy or excessive daytime sleepiness, LUMRYZ enables users to take a full therapeutic dose before bed — eliminating the need to wake in the middle of the night for a second dose and potentially improving sleep quality.