Avadel Pharmaceuticals plc, a company focused on developing FT218, an investigational once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy, has achieved its patient enrollment target of 205 patients in the REST-ON Phase 3 clinical trial for FT218.
The FDA recently agreed to Avadel’s amendment to lower enrollment to 205 patients.
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 topline data expected in the second quarter of 2020.
“Achieving the patient enrollment target in the pivotal REST-ON study marks an important milestone in our development efforts for our lead asset, FT218. We expect to announce topline data from the study in the second quarter of 2020, as we continue to advance this program towards submission for regulatory approval,” says Jordan Dubow, MD, chief medical officer, in a release. “Being able to accelerate this achievement by up to 12 months is a testament to the hard work of the study investigators, staff, and patients, as well as the Avadel team.”
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.