Avadel Pharmaceuticals (NASDAQ:AVDL) reported positive topline data from its Phase 3 trial of FT218 for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy.
The Phase 3 study, called REST-ON, enrolled 212 patients to assess three doses of FT218, a once-nightly formulation of sodium oxybate. The trial met its three co-primary efficacy endpoints at all three doses (six, 7.5 and nine grams), demonstrating significant improvements on the Maintenance of Wakefulness Test, Clinical Global Impression-Improvement rating scale and mean weekly cataplexy attacks.
“We are excited to see these positive topline data from the REST-ON study, where all three dose levels of once-nightly FT218 demonstrated a statistically significant and clinically meaningful improvement on the measures of the two prominent symptoms of narcolepsy, as well as an improvement in overall functioning compared to placebo,” Dr. Jordan Dubow, Avadel’s CMO, said in a statement.
Greg Divis, Avadel’s CEO, added, “We look forward to sharing the results from the REST-ON study with the FDA and progressing toward a potential approval that would allow us to bring this important treatment to the patients who need it most. If approved, FT218 would be the first once-nightly therapy to address both excessive daytime sleepiness and cataplexy in patients with narcolepsy.”
