The data from Avadel Pharmaceuticals plc’s pivotal Phase 3 REST-ON trial of FT218 is now published in the journal SLEEP.
“The publication of the REST-ON trial results in the peer-reviewed journal SLEEP validates the potential of FT218 as a once-at-bedtime option that could, if approved, transform the treatment landscape for adults suffering from the burdensome symptoms of narcolepsy,” says Jennifer Gudeman, PharmD, vice president of medical and clinical affairs at Avadel, in a release. “We believe FT218 has tremendous potential to provide clinically meaningful results for people with narcolepsy. As we approach our October PDUFA date, we remain confident in the potential of FT218 and are committed to making FT218 accessible to patients, if approved.”
Topline data from the completed randomized, double-blind, placebo-controlled REST-ON trial were announced in April 2020. The study was designed to investigate the efficacy and safety of once-at-bedtime FT218 for the treatment of EDS and cataplexy in patients with narcolepsy. FT218 is currently under review at the US Food and Drug Administration with a Prescription Drug User Fee Act target date of October 15, 2021.