AVDL - Avadel stock falls 26% as FDA cites patent issue in sleep disorder drug FT218 filing; expects tentative approval in 2023

Avadel Pharmaceuticals (NASDAQ:AVDL) stock fell ~26% on May 26 after the company said it received a proposed, final label and medication guide for its sleep disorder drug FT218 from the U.S. Food & Drug Administration (FDA). In October 2021, the FDA had delayed to approve the company's new drug application (NDA) for FT218 excessive daytime sleepiness and cataplexy in adults with narcolepsy as said it needed more time to review. Avadel said in a May 26 SEC filing that FDA noted that the FT218 NDA patent statement related to US Patent No. 8,731,963 (the REMS patent) was deemed inappropriate by the FDA. FDA has asked the company to add a certification to the REMS patent to its NDA. The company noted that the FDA confirmed, based on the final proposed label, that no additional patent certifications will be required. Avadel (AVDL) said that it now expects tentative approval of the FT218 NDA with potential full approval on

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Avadel stock falls 26% as FDA cites patent issue in sleep disorder drug FT218 filing; expects tentative approval in 2023