Avadel Pharmaceuticals announces favorable ruling in appeal of injunction

Avadel Pharmaceuticals (AVDL) announced that the United States Court of Appeals for 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 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. Patient enrollment in Avadel’s REVITALYZ trial remains on track to be completed by the end of 2025. REVITALYZ is a double-blind, placebo-controlled, randomized withdrawal, multicenter Phase 3 study designed to evaluate the efficacy and safety of LUMRYZ given as a once-at-bedtime dose, in IH. The study will enroll approximately 150 adults who are diagnosed with IH and is open for participants switching from immediate-release oxybates and to those not currently taking oxybates.