Avadel Pharmaceuticals (NASDAQ:AVDL) completed enrollment in its pivotal trial assessing FT218 for excessive daytime sleepiness and cataplexy in patients with narcolepsy.
The Phase 3 study, called REST-ON, enrolled 212 patients, exceeding the target enrollment of 205 patients. The study will assess FT218, a once-nightly formulation of sodium oxybate, with topline data expected in the second quarter of 2020.
“We’ve experienced strong interest in FT218 and the REST-ON study from across the narcolepsy community, which we believe is mostly centered around the once-nightly dosing formulation of FT218,” Dr. Jordan Dubow, Avadel’s CMO, said in a statement.
“FT218’s once-nightly dosing may be safer in treating patients with narcolepsy than the previously-approved sodium oxybate product due to that product’s twice-nightly dosing regimen,” he added.
