Avadel Pharma Announces Favorable Ruling As Court Supports FDA's Approval Of LUMRYZ

(RTTNews) - Avadel Pharmaceuticals plc (AVDL), Monday announced a significant ruling made by the U.S. Court of Appeals for the District of Columbia Circuit, favoring the U.S. Food and Drug Administration's approval of LUMRYZ, a treatment for cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy.

The latest decision upholds a previous ruling made by the U.S. District Court for the District of Columbia in a lawsuit brought by Jazz Pharmaceuticals Inc.

CEO Greg Divis, stated, "The ruling affirms the FDA's decision, which the Appeals Court noted was undisputed, that LUMRYZ's once-at-bedtime dosing is clinically superior to all first generation, immediate-release oxybates and provides a major contribution to patient care."

Notably, the FDA's approval of LUMRYZ was backed by findings from REST-ON Phase 3 trial, where the treatment showed statistically significant and clinically meaningful improvements in EDS, clinicians' overall assessment of patients' functioning, and cataplexy attacks.

Friday, AVDL closed at $9.20, down 0.97 percent on the Nasdaq.