Benzinga | Aug 16, 2021 08:02AM EDT

Avadel Pharmaceuticals Announces Publication of Data from Pivotal Phase 3 REST-ON Trial of FT218 in Adults with Narcolepsy in SLEEP

Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness (EDS) and cataplexy in adults with narcolepsy, announced today the publication of data from its pivotal Phase 3 REST-ON trial of FT218 in SLEEP, the journal of the Sleep Research Society. The paper, titled "Once-Nightly Sodium Oxybate (FT218) Demonstrated Improvement of Symptoms in a Phase 3 Randomized Clinical Trial in Patients With Narcolepsy," can be accessed at https://academic.oup.com/sleep/advance-article/doi/10.1093/sleep/zsab200/6343406?searchresult=1.

"The publication of the REST-ON trial results in the peer-reviewed journal SLEEP validates the potential of FT218 as a once-at-bedtime option that could, if approved, transform the treatment landscape for adults suffering from the burdensome symptoms of narcolepsy," said Jennifer Gudeman, Pharm.D., Vice President of Medical and Clinical Affairs at Avadel. "We believe FT218 has tremendous potential to provide clinically meaningful results for people with narcolepsy. As we approach our October PDUFA date, we remain confident in the potential of FT218 and are committed to making FT218 accessible to patients, if approved."

Topline data from the completed randomized, double-blind, placebo-controlled REST-ON trial were announced in April 2020. The study was designed to investigate the efficacy and safety of once-at-bedtime FT218 for the treatment of EDS and cataplexy in patients with narcolepsy. FT218 is currently under review at the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target date of October 15, 2021.