Avadel Pharmaceuticals to Present New Data on LUMRYZ™ (sodium oxybate) For Extended-Release Oral Suspension at SLEEP 2025

Core Insights - Avadel Pharmaceuticals is presenting new data on LUMRYZ, a treatment for narcolepsy, at the SLEEP 2025 conference, highlighting its efficacy and real-world impact on patients [1][2][3] Group 1: Efficacy and Clinical Data - Interim analysis of the REFRESH study shows significant improvement in excessive daytime sleepiness (EDS) for patients switching from twice-nightly oxybate to once-at-bedtime LUMRYZ [1][2] - Post-hoc analysis from the Phase 3 REST-ON trial indicates that LUMRYZ participants with severe sleepiness achieved median Epworth Sleepiness Scale (ESS) scores within the normal range by Week 13 [2][3] - Data from the REFRESH study indicates that 67 patients, including those new to oxybate and those switching from twice-nightly oxybate, experienced clinically significant reductions in sleepiness [3][4] Group 2: Safety and Tolerability - A post-hoc analysis from the RESTORE study involving 115 participants showed that only 4% discontinued LUMRYZ due to treatment-related adverse events, indicating long-term tolerability [3][4] - The safety profile of LUMRYZ aligns with known adverse events of oxybates, with no worsening of apnea-hypopnea index (AHI) observed in patients with mild sleep apnea [2][3] Group 3: Regulatory and Market Position - LUMRYZ received FDA approval as the first and only once-at-bedtime treatment for cataplexy or EDS in adults and pediatric patients with narcolepsy, supported by significant clinical trial results [6][7][8] - The FDA granted LUMRYZ 7 years of Orphan Drug Exclusivity due to its clinical superiority over existing treatments, emphasizing its once-nightly dosing regimen [8][9] Group 4: Conference Presentations - Avadel will present 14 abstracts, including four oral presentations, at SLEEP 2025, focusing on the benefits of LUMRYZ for narcolepsy patients [1][3] - Key presentations will cover topics such as the long-term safety of LUMRYZ, improvements in daytime sleepiness, and the impact on sleep-related eating disorder [4][5]