Skip to Content
Global News Select

Avadel Pharma Gets Tentative FDA Approval for Lumryz

By Chris Wack

 

Avadel Pharmaceuticals PLC said the U.S. Food and Drug Administration granted tentative approval to Lumryz, also known as FT218.

The tentative approval indicates that Lumryz has met all required quality, safety, and efficacy standards necessary for approval in the U.S., the biopharmaceutical company said.

Final approval is pending disposition of a U.S. patent, which is listed in the FDA's Orange Book.

Lumryz is a once-at-bedtime investigational formulation of sodium oxybate for the treatment of excessive daytime sleepiness or cataplexy in adults with narcolepsy.

The company said it is pursuing all options to accelerate final approval on or before June 2023 and prepare for commercial launch.

Avadel shares were up 9% to $4.66 in premarket trading.

 

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

 

(END) Dow Jones Newswires

July 19, 2022 07:43 ET (11:43 GMT)

Copyright (c) 2022 Dow Jones & Company, Inc.