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Investing.com -- Avadel Pharmaceuticals PLC (NASDAQ:AVDL) stock rose 4.7% after a U.S. appeals court unanimously upheld the FDA’s approval of LUMRYZ, the company’s once-at-bedtime treatment for narcolepsy, in litigation brought by Jazz Pharmaceuticals (NASDAQ:JAZZ).
The U.S. Court of Appeals for the District of Columbia Circuit on Friday affirmed a previous district court ruling that favored the FDA in the Administrative Procedure Act lawsuit. The decision ensures LUMRYZ, the first and only once-nightly oxybate treatment for narcolepsy, can continue to be available to 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, Chief Executive Officer at Avadel Pharmaceuticals.
The legal battle began when Jazz Pharmaceuticals challenged the FDA’s approval of LUMRYZ. After the district court ruled in favor of the FDA and Avadel in October 2024, Jazz appealed the decision. The appeals court panel unanimously affirmed the lower court’s ruling on June 27.
According to Avadel, the appeals court noted it was "undisputed" that LUMRYZ’s once-at-bedtime dosing is clinically superior to first-generation, immediate-release oxybates and provides a major contribution to patient care.
LUMRYZ is approved for treating cataplexy or excessive daytime sleepiness in narcolepsy patients aged 7 and older. The medication allows patients to take a full therapeutic dose at bedtime, potentially enabling an uninterrupted night’s sleep.
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