Avadel Pharma (AVDL) announces favorable ruling in LUMRYZ case

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.

“We are pleased with the Federal Circuit’s decision, which paves the way for Avadel to initiate new clinical trials, offer open-label extensions in clinical trials, and ultimately seek FDA approval of LUMRYZ in IH as well as other indications,” stated Greg Divis, Chief Executive Officer of Avadel. “We remain relentlessly committed to demonstrating the clinical value of our differentiated, extended-release, once-at-bedtime medication.”

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.

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