Avadel: Avadel Pharmaceuticals Provides Update at Needham Virtual Healthcare Conference

DUBLIN, April 08, 2025 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today presented at the 24th Annual Needham Virtual Healthcare Conference.The Company provided an update on patient demand metrics that was in line with guidance from its full-year results announcement on March 3, 2025. It also addressed questions related to the recent developments in United States tariff policy and the potential impact on the biopharmaceutical sector, including Avadel.Specifically:In Q1 2025 patient demand metrics for LUMRYZ , Avadel's innovative narcolepsy medication with a market potential of a billion dollars in peak annual sales, all improved versus Q4 2024. These improvements include patient enrollments, patient starts, persistency rates, and net patients on therapy.REVITALYZ , the Company's Phase 3 pivotal trial studying LUMRYZ in Idiopathic Hypersomnia (IH), is on track to complete enrollment in the second half of 2025.Avadel has initiated four patent infringement lawsuits against Jazz Pharmaceuticals since the beginning of 2025, alleging certain uses of Jazz's Xywav product, according to its corresponding labeling, infringe claims of five different Avadel patents.The Company expects to generate sustainable positive cash flow in 2025.Regarding the potential impact of possible changes in U.S. tariff policies, Avadel has developed a diversified supply chain over the past three years for LUMRYZ.The active pharmaceutical ingredient ("API") in LUMRYZ is sodium oxybate, which is manufactured by two contract development and manufacturing organizations ("CDMOs") located in the U.S. and approved by the U.S. Food and Drug Administration. Accordingly, the U.S. is the country of origin for all the API in LUMRYZ. The finished LUMRYZ commercial product is approved to be manufactured by one outsourced CDMO located in the U.S. and another in Europe. Additionally, all primary packaging of LUMRYZ is conducted in the U.S.In summary, these efforts have strengthened supply chain security and, if needed, the capability to manufacture LUMRYZ entirely in the U.S.An archived recording of the fireside chat webcast will be available on Avadel's Investor Relations website, investors.avadel.com, for 90 days following the conference.About LUMRYZ (sodium oxybate) for extended-release oral suspensionLUMRYZ is an extended-release sodium oxybate medication approved by the FDA on May 1, 2023, as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. On October 16, 2024, LUMRYZ was additionally approved as a once-at-bedtime treatment for cataplexy or EDS in pediatric patients 7 years of age and older with narcolepsy.The FDA approval of LUMRYZ was supported by results from REST-ON , a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial in adults with narcolepsy. LUMRYZ demonstrated statistically significant and clinically meaningful improvements in the three co-primary endpoints: EDS (MWT), clinicians' overall assessment of patients' functioning (CGI-I), and cataplexy attacks, for all three evaluated doses when compared to placebo. With its approvals in May 2023 and October 2024, the FDA also granted 7 years of Orphan Drug Exclusivity to LUMRYZ for the treatment of cataplexy or EDS in adults with narcolepsy and in pediatric patients 7 years of age and older with narcolepsy (respectively) due to a finding of clinical superiority of LUMRYZ relative to currently available oxybate treatments. In particular, the FDA found that LUMRYZ makes a major contribution ...Full story available on Benzinga.com