Avadel pharmaceuticals achieves enrollment target in rest-on phase 3 pivotal trial of ft218 for excessive daytime sleepiness and cataplexy in patients with narcolepsy

Avadel pharmaceuticals plc announced that it has achieved its patient enrollment target of 205 patients in the rest-on phase 3 clinical trial for its once-nightly sodium oxybate, ft218. additional patients currently in the screening process will also be allowed to enroll in the study if they meet eligibility criteria. the last patient’s last visit is expected to occur by the end of the first quarter of 2020, with top line data expected in the second quarter of 2020. the rest-on study is a double-blind, randomized, placebo-controlled phase 3 trial to assess the efficacy and safety of once-nightly ft218, a formulation of sodium oxybate using avadel’s proprietary micropump™ technology for extended-release oral suspension, in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. the rest-on study is under a special protocol assessment agreement with fda.
AVDL Ratings Summary
AVDL Quant Ranking