UPDATE: Federal Circuit Lifted The Portions Of The Delaware Court's Injunction That Prohibited Avadel From Offering Open-Label Extensions To Trial Participants Using LUMRYZ And From Initiating New Clinical Trials Or Studies With LUMRYZ For Potential Indications Beyond Narcolepsy

Avadel Pharmaceuticals plc (NASDAQ:AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today announced that the United States Court of Appeals for the Federal Circuit (the "Federal Circuit") has ruled in favor of Avadel, overturning important parts of the injunction imposed by the U.S. District Court for the District of Delaware (the "Delaware Court") regarding LUMRYZ™ as a potential treatment of indications beyond narcolepsy.

The Federal Circuit vacated the portion of the injunction that prohibited Avadel from applying for FDA approval of LUMRYZ for any indication beyond narcolepsy, calling the district court's analysis "simply too speculative and tenuous." Additionally, the Federal Circuit lifted the portions of the Delaware Court's injunction that prohibited Avadel from offering open-label extensions to trial participants using LUMRYZ and from initiating new clinical trials or studies with LUMRYZ for potential indications beyond narcolepsy.