Appeals Court Affirms Favorable FDA Ruling for Avadel in Lumryn Litigation

Published: 2025-06-30 08:25:12 ET AVDL

Published on 06/30/2025 at 08:25

By Connor Hart

Avadel Pharmaceuticals said an appeals court affirmed a prior decision in favor of the Food and Drug Administration regarding litigation with Jazz Pharmaceuticals, its biggest competitor for narcolepsy treatments, over patent concerns.

The Dublin-based biopharmaceutical company said Monday that the ruling, in the U.S. Court of Appeals for the District of Columbia, affirmed a prior decision that upheld the approval of Avadel's narcolepsy treatment, Lumryz, based on the FDA's determination that Lumryz is clinically superior to Jazz's twice-nightly oxybate products.

The U.S. District Court for the District of Columbia issued its ruling in October, after which Jazz filed a notice of appeal to the Appeals Court. The Appeals Court affirmed the District Court's ruling and upheld the FDA's approval of Lumryz on Friday, Avadel said.

"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," Avadel Chief Executive Greg Divis said.

With the ruling, Lumryz will continue to be available for narcolepsy patients. Looking forward, Avadel will continue to advance its commercial strategy, aiming to transform the sleep-treatment paradigm for the narcolepsy community and increase the number of patients treated with Lumryz, Divis added.

Avadel shares rise 3.3%, to $9.50, in premarket trading. The stock has fallen about 35% in the past year.

The disclosure came after The Wall Street Journal reported Sunday that an Avadel investor plans to call for shareholders to vote out the company's entire board of directors.

Write to Connor Hart at [email protected]

(END) Dow Jones Newswires

06-30-25 0824ET