Avadel Pharmaceuticals Announces Submission of New Drug Application for FT218 to the FDA
DUBLIN, Ireland, December 16, 2020 -- Avadel Pharmaceuticals plc (Nasdaq: AVDL) today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy.
“The submission of our NDA represents a significant milestone for the Company. We look forward to working with the FDA during the NDA review process in order to get once-nightly FT218 approved and commercially available to patients with narcolepsy who suffer from excessive daytime sleepiness and cataplexy,” said Greg Divis, Chief Executive Officer of Avadel. “If approved, we believe once-nightly FT218 has the potential to provide a valuable treatment option for sodium oxybate eligible narcolepsy patients, including those who are not satisfied with the current twice-nightly treatment, which requires waking up in the middle of the night to take a second dose.”
About FT218
FT218 is an investigational, once-nightly formulation of Micropump™ controlled-release (CR) sodium oxybate. In March of 2020, the Company completed the REST-ON study, a pivotal, double-blind, randomized, placebo-controlled Phase 3 trial, to assess the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that FT218 may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the FDA for the same indication. In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously approved product.
