Avadel Pharmaceuticals Announces Favorable Ruling on Motion to Delist REMS Patent from FDA’s Orange Book
– Delisting of REMS Patent sets path to potentially accelerate final approval by FDA
DUBLIN, Ireland, Nov. 18, 2022 (GLOBE NEWSWIRE) — Avadel Pharmaceuticals plc (Nasdaq:AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that the United States District Court for the District of Delaware (the “Delaware Court”) ordered Jazz Pharmaceuticals to delist U.S. Patent No. 8731963 (the “REMS Patent”) from the U.S. Food and Drug Administration’s (“FDA”) Orange Book. With this decision, Avadel seeks to accelerate the FDA’s final approval decision for LUMRYZ™, a once-at-bedtime investigational formulation of sodium oxybate for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.