FT218 – Avadel’s Lead Investigational Therapy
Avadel’s FT218 is an investigational, extended-release formulation of sodium oxybate designed to be taken once at bedtime to treat excessive daytime sleepiness (EDS) and cataplexy in patients suffering from narcolepsy.
In March 2020, Avadel completed the pivotal Phase 3 REST-ON study, a double-blind, randomized, placebo-controlled trial to assess the efficacy and safety of FT218 in the treatment of EDS and cataplexy in patients suffering from narcolepsy. Topline data from the trial, announced in April 2020, demonstrated that all three evaluated doses of FT218 demonstrated statistically significant changes and clinically meaningful results in reducing EDS, improving the clinician’s overall assessment of the patients functioning, and reducing cataplexy attacks in those with narcolepsy type 1, when compared to placebo.
FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy based upon the plausible hypothesis that FT218 may be clinically superior to a formulation of sodium oxybate that is already approved by the FDA for those with narcolepsy. In particular, once-nightly FT218 may be safer due to ramifications associated with the dosing regimen of the currently available, twice-nightly product.
The FDA is currently reviewing Avadel’s New Drug Application (NDA) for FT218 to treat EDS and cataplexy in adults diagnosed with narcolepsy, with a Prescription Drug User Fee Act (PDUFA) target action date of October 15, 2021.
Recent data presentations can be viewed at https://sleep2021.avadelmedicalbooth.com.