By Denny Jacob

 

American depositary receipts of Avadel Pharmaceuticals tumbled 14% to $13.13 on Friday after a lawsuit was filed in the U.S. District Court for the District of Columbia alleging that the U.S. Food and Drug Administration unlawfully approved the company's new drug application for Lumryz.

Avadel's ADRs, which are up 83% on the year, are on pace for their largest percentage decrease since May 2022 when they fell over 68%.

Ireland-based biopharmaceutical company Jazz Pharmaceuticals said Thursday in a regulatory filing that its lawsuit alleged that the FDA acted outside its authority under the Orphan Drug Act when it approved Lumryz's new drug application and granted it orphan drug exclusivity.

The lawsuit alleged the FDA acted without lawful basis when the agency determined that Lumryz boosted patient care and was purportedly clinically superior to two similar drugs that Jazz Pharmaceutical produces, Xywav and Xyrem.

Jazz Pharmaceuticals said Xywav already had orphan drug exclusivity and described Lumryz as an extended-release reformulation of Xyrem. The drugs treat cataplexy, or excessive daytime sleepiness, in adults with narcolepsy.

Avadel Pharmaceuticals didn't immediately respond to a request for comment from Dow Jones Newswires.

 

Write to Denny Jacob at denny.jacob@wsj.com

 

(END) Dow Jones Newswires

June 23, 2023 11:57 ET (15:57 GMT)

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