Avadel Pharmaceuticals plc announced the steps it is taking to explore every available pathway to accelerate the decision by the U.S. Food and Drug Administration (FDA) to grant final approval of its lead drug candidate, FT218, prior to June 2023. Concurrent with this strategy, Avadel has received and agreed upon what is expected to be a final label and is completing the last edits of the Risk Evaluation and Mitigation Strategy (“REMS”) with FDA and expects to receive tentative approval of FT218. Avadel, in alignment with most important priorities, is taking the following actions, including those that can potentially accelerate FDA's final approval decision and shorten the timeline between approval and launch of FT218: Submitted a Paragraph IV patent certification and expects to receive a tentative approval.

Filed a motion in the U.S. District Court of Delaware to delist US Patent No. 8,731,963 (the REMS patent), from FDA's Orange Book. A court order requiring the patent holder to delist the REMS patent from the Orange Book could provide a pathway for a final approval of FT218 prior to June 2023.

Preparing for a claim construction hearing (Markman hearing) in the existing patent litigation in the U.S. District Court of Delaware which is scheduled for August 31, 2022. The Court has previously stated this claim construction hearing needs to take place prior to ruling on the motion to delist the REMS patent from the Orange Book. Investing in patient and physician education including the Company's disease state program, which has resulted in over 5,000 narcolepsy patient enrollments in the first half of 2022.

Continuing key activities in anticipation of a final approval on or before June 2023, including planning for the final preparation of the FT218 REMS program and the continued manufacturing of commercial supply.