By Chris Wack

Avadel Pharmaceuticals Plc shares were down 42% to $1.97 after the company said in a filing that it received a proposed, final label and medication guide for FT218 from the U.S. Food & Drug Administration.

FT218 is the company's lead drug candidate, an investigational formulation of sodium oxybate designed to be taken once at bedtime for the treatment of excessive daytime sleepiness or cataplexy in adults with narcolepsy.

The company also said it was notified by the FDA that the FT218 New Drug Application patent statement pertaining to its U.S. REMS patent was deemed inappropriate by the FDA.

The FDA has requested the company add a certification to the REMS patent to its NDA. The FDA further confirmed, based on the final proposed label, that no additional patent certifications will be required.

Avadel now anticipates tentative approval of the FT218 NDA with potential full approval on or before the expiration of the REMS patent on June 17, 2023. Full approval could occur sooner if the REMS patent is delisted from the FDA's Orange Book, a court determines the patent is invalid, not infringed or otherwise unenforceable, or a court determines that the FDA erred in requesting a certification.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

May 26, 2022 10:05 ET (14:05 GMT)

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