Avadel Pharmaceuticals Announces Favorable Ruling On Lumryz

Avadel Pharmaceuticals plc , a biopharmaceutical company focused on transforming medicines to transform lives, announced that yesterday, the U.S. District Court for the District of Columbia (“Court”) ruled in favor of the Food and Drug Administration (“FDA”) in a suit brought by Jazz Pharmaceuticals Inc. (“Jazz”) under the Administrative Procedure Act regarding the FDA’s approval of LUMRYZ^TM, the first and only once-at-bedtime oxybate treatment for cataplexy or excessive daytime sleepiness in adults with narcolepsy. With this ruling, the approval of LUMRYZ is upheld based on the FDA’s determination that LUMRYZ is clinically superior to Jazz’s twice-nightly oxybate products.

Following the FDA’s final approval and grant of Orphan Drug Exclusivity (“ODE”) to LUMRYZ in May 2023, Jazz filed a complaint against the FDA claiming that LUMRYZ’s approval was not in alignment with the Orphan Drug Act. Avadel CNS Pharmaceuticals, LLC (“Avadel CNS”) intervened to defend the FDA’s actions and successfully argued to uphold approval of LUMRYZ.

“We are pleased with the Court’s ruling in favor of the FDA’s clinical superiority determination for LUMRYZ in conjunction with final approval for use in adults with narcolepsy. With the Court’s decision, LUMRYZ will continue to be available to the narcolepsy community and retain its Orphan Drug Exclusivity,” said Greg Divis, Chief Executive Officer at Avadel Pharmaceuticals. “Yesterday’s ruling further solidifies LUMRYZ’s unique once-at-bedtime dosing schedule as a major contribution to patient care and enables us to continue executing on our commercial launch and expanding LUMRYZ’s reach within the narcolepsy community.”

Source: Avadel Pharmaceuticals