FDA setback for Avadel Pharma's narcolepsy candidate

Ireland-incorporated Avadel Pharmaceuticals’ (Nasdaq: AVDL) shares fell as much as 63% on Thursday after the company disclosed, in a filing with the US Securities and Exchange Commission (SEC), that it had received a proposed, final label and medication guide for FT218 from the US Food and Drug Administration (FDA).

Avadel is developing FT218, an investigational formulation of sodium oxybate designed to be taken once at bedtime, for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy.

In addition, the company was notified by the FDA that the FT218 New Drug Application (NDA) patent statement pertaining to US Patent No 8,731,963 (the REMS patent) was deemed inappropriate by the agency. As such, the FDA has requested the company add a certification to the REMS patent to its NDA.