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Avadel Pharmaceuticals to Present New Data on LUMRYZ™ (sodium oxybate) for Extended-Release Oral Suspension at World Sleep 2025
Globenewswire· 2025-09-05 12:00
Core Insights - Avadel Pharmaceuticals presented new data on LUMRYZ, a once-nightly sodium oxybate treatment for narcolepsy, at World Sleep 2025, highlighting its efficacy in improving symptoms for both new and returning patients [1][2][3] Group 1: Efficacy of LUMRYZ - The REFRESH study demonstrated that patients switching from twice-nightly oxybate to LUMRYZ experienced clinically meaningful improvements in excessive daytime sleepiness (EDS) and other narcolepsy symptoms [4] - 70% of switch participants and 90% of non-switch participants reported improvement on the Patient Global Impression of Change after 4 months of therapy [4] - The study also indicated a reduction in severity of narcolepsy symptoms from moderate to mild, with significant improvements in quality of life metrics such as fatigue, brain fog, and mood [4] Group 2: Presentation Highlights - A total of 17 abstracts were accepted for presentation at World Sleep 2025, including one oral presentation and 16 posters, focusing on the benefits of LUMRYZ [1][2] - Presentations reinforced the advantages of LUMRYZ in addressing hallmark symptoms of narcolepsy, including EDS and sleep-related hallucinations [3] Group 3: Regulatory and Market Position - LUMRYZ is the first and only once-at-bedtime treatment for cataplexy or EDS in patients aged seven years and older with narcolepsy, receiving FDA approval in May 2023 and October 2024 [8][10] - The FDA granted LUMRYZ seven years of Orphan Drug Exclusivity due to its clinical superiority over existing treatments, emphasizing its once-nightly dosing regimen [10]
Avadel Pharmaceuticals (AVDL) Earnings Call Presentation
2025-06-27 14:55
LUMRYZ Opportunity and Strategy - LUMRYZ aims to transform the narcolepsy treatment market and Avadel into a high-growth biopharmaceutical company[5] - The company has a clear strategy for significant growth and value creation, building on a strong foundation[8] - Avadel has a focused strategy with clear priorities, including driving demand, securing reimbursement, and investing in lifecycle management[20, 21, 22] - LUMRYZ has significant potential for future peak revenue, potentially exceeding $1 billion, with a target market share of 50-60% and a potential patient base exceeding 10,000[27, 28] LUMRYZ Differentiation and Clinical Data - LUMRYZ is a new and highly differentiated treatment for narcolepsy, addressing an unmet need for a once-at-bedtime oxybate[6, 13] - 94% of patients who switched from first-generation oxybates prefer LUMRYZ dosing[13] - The FDA has determined LUMRYZ to be clinically superior to twice-nightly oxybates, granting it Orphan Drug Exclusivity (ODE)[13, 63] - Clinical data supports LUMRYZ's efficacy, with the REST-ON Phase III study achieving statistical significance (P<0.001) for all three co-primary endpoints[57] Launch and Market Dynamics - The oxybate narcolepsy market has plateaued at approximately $18 billion with approximately 16,000 patients[178] - Approximately 45% of oxybate-naive patients refuse first-generation oxybates when offered[186] - Market research indicates that LUMRYZ has the potential to expand the new-to-oxybate patient market by +35% to 113%[84] - The company's field team has reached approximately 1,100 sleep specialist offices, representing 66% of top-tier targets[250]
Avadel Pharmaceuticals to Present New Data on LUMRYZ™ (sodium oxybate) For Extended-Release Oral Suspension at SLEEP 2025
Globenewswire· 2025-05-29 20:05
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]