As previously disclosed, on June 22, 2023, Jazz Pharmaceuticals, Inc. ("Jazz") filed an Administrative Procedure Act ("APA") suit against the U.S. Food and Drug Administration (the "FDA"), the U.S. Department of Health and Human Services, the Secretary of Health and Human Services and the Commissioner of Food and Drugs in the United States District Court for the District of Columbia (the "D.C. Court") related to the New Drug Application for LUMRYZ. This suit alleged that the FDA's approval of LUMRYZ was an unlawful agency action and asked the D.C. Court to set aside FDA's approval of LUMRYZ.

On October 30, 2024, the D.C. Court granted the FDA and Avadel Pharmaceuticals plc's Motions for Summary Judgment with respect to the sole count in Jazz's complaint and denied Jazz's Motion for Summary Judgment regarding the same. On November 15, 2024, Jazz filed a notice of appeal to the United States Court of Appeals for the District of Columbia Circuit (the "D.C. Court of Appeals") concerning the D.C. Court's October 30, 2024 ruling.

On June 27, 2025, the D.C. Court of Appeals, in a unanimous decision, affirmed the D.C. Court's ruling and upheld the FDA's approval of LUMRYZ.