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Avadel Pharmaceuticals Achieves Enrollment Target in REST-ON Phase 3 Pivotal Trial of FT218 for Excessive Daytime Sleepiness and Cataplexy in Patients with Narcolepsy
205 patients enrolled; additional patients currently in screening will be allowed to enroll if eligible
Topline data from the REST-ON study expected in Q2 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,” stated Dr.
Based on the Company’s industry research, it believes FT218, if approved by the
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
FT218 is an investigational, once-nightly formulation of Micropump™ controlled-release (CR) sodium oxybate. The company is currently conducting the REST-ON study, a double-blind, randomized, placebo-controlled Phase 3 trial, to assess the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. FT218 has been granted Orphan Drug Designation from the
1. Annualized Xyrem revenues from Jazz Pharmaceuticals Q3 2019 earnings press release, November 5, 2019
About Avadel Pharmaceuticals plc:
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Source: Avadel Pharmaceuticals plc