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Avadel Says Appeals Court Upholds FDA Approval of Lumryz for Narcolepsy
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Avadel Says Appeals Court Upholds FDA Approval of Lumryz for Narcolepsy
Jun 30, 2025 5:39 AM

08:18 AM EDT, 06/30/2025 (MT Newswires) -- Avadel Pharmaceuticals ( AVDL ) said Monday the US Court of Appeals for the District of Columbia upheld the US Food and Drug Administration's approval of Lumryz in a case brought by Jazz Pharmaceuticals ( JAZZ ) .

The ruling issued Friday affirmed a 2024 district court decision that supported the FDA's approval of Lumryz for treating cataplexy or excessive daytime sleepiness in patients with narcolepsy, the company said.

Lumryz is a once-at-bedtime sodium oxybate therapy and will continue to be available for patients 7 years old and older, Avadel said.

Jazz did not immediately respond to MT Newswires' request for comment.

Shares of Avadel added 4.9% in recent premarket activity, while Jazz's shares were up slightly.

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