Avadel Pharmaceuticals plc (NASDAQ:AVDL) saw its shares decrease in price after the U.S. Food and Drug Administration notified the company that the review of its marketing application for FT218 is still ongoing, and action will likely not be taken in October.
The FDA informed the Dublin-based company there are no information requests and will provide a new target action date as soon as possible.
According to CEO Greg Divis, "We have addressed all questions received to date and remain confident that the package we have submitted satisfies all of the FDA's requests. We have not been informed of any deficiencies in our application and remain fully committed to work closely with the FDA for the duration of its review of our NDA for FT218."
FT218 is an investigational formulation of sodium oxybate leveraging Avadel’s proprietary drug delivery technology and designed to be taken once at bedtime for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy.
In March 2020, Avadel completed the REST-ON study, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial, to assess the efficacy and safety of FT218 in patients with narcolepsy. Among the three co-primary endpoints, FT218 demonstrated statistically significant and clinically meaningful results in EDS, the clinician’s overall assessment of the patient’s functioning, and reduction in cataplexy attacks, for all three evaluated doses when compared to placebo.
AVDL shares are down $1.20, or 12% at $8.79 first thing Monday.
