Avadel Pharmaceuticals PLC shares were down 21% to $7.91 in premarket trading after the company said Friday that the U.S. Food and Drug Administration’s review of the new drug application for FT218 is still ongoing and action will likely not be taken in October.
The company said the FDA notified the company that there are no information requests at this time and a new target action date would be provided as soon as possible.
FT218 is designed to be taken once at bedtime for the treatment of excessive daytime sleepiness or cataplexy in adults with narcolepsy.
Avadel said it has addressed all questions received to date, and it remains confident that the package it have submitted satisfies all of the FDA’s requests. It hasn’t been informed of any deficiencies in its application.
In February, the FDA accepted Avadel’s application for FT218 and assigned a target action date of Oct. 15. The NDA submission is supported by data from a Phase 3 study.