Avadel Pharmaceuticals Achieves Enrollment Target in REST-ON Phase 3 Pivotal Trial

Avadel Pharmaceuticals plc recently announced 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 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 toward submission for regulatory approval,” said Dr. Jordan Dubow, Chief Medical Officer. “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.”

Based on the company’s industry research, it believes FT218, if approved by the FDA, has the potential to take a significant share of the twice-nightly sodium oxybate market. Currently, this market is valued at an estimated annualized rate of $1.7 billion.

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.

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 US FDA for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that FT218 may be clinically superior to a twice-nightly formulation of sodium oxybate already approved by the FDA for the same indication. In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously-approved product.

Avadel Pharmaceuticals plc (Nasdaq: AVDL) is an emerging biopharmaceutical company. The Company’s primary focus is the development and potential FDA approval of FT218, which is in a Phase 3 clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness (EDS) and cataplexy. In addition, Avadel develops and markets a portfolio of sterile injectable drugs used in the hospital setting. For more information, visit www.avadel.com.