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Avadel Pharmaceuticals Shares New LUMRYZ™ (sodium oxybate) For Extended-release Oral Suspension (CIII) Data at SLEEP 2024
AVDLAvadel Pharmaceuticals plc(AVDL) globenewswire.com·2024-05-22 20:00

文章核心观点 - 公司将在SLEEP 2024会议展示多项研究数据支持LUMRYZ作为发作性睡病治疗选择,其具有有效性和患者偏好优势 [1][2] 公司动态 - 公司宣布将在SLEEP 2024会议上展示11篇海报和1场口头报告,支持LUMRYZ作为发作性睡病治疗选择 [1] - 公司将在6月4日为美国医疗专业人士举办产品研讨会,主题为“不断发展的发作性睡病护理:关于LUMRYZ的专家观点” [5] LUMRYZ药物信息 - LUMRYZ是首个也是唯一的缓释羟丁酸钠制剂,2023年获FDA批准,用于治疗成人发作性睡病的猝倒或白天过度嗜睡症状 [1][6] - FDA基于REST - ON试验结果批准LUMRYZ,并授予其七年孤儿药独家经营权,因其相对现有羟丁酸盐治疗具有临床优势 [6][7] 研究数据亮点 - RESTORE研究显示患者对睡前一次服用LUMRYZ满意度高,症状控制改善、用药依从性提高,且更偏好LUMRYZ而非每晚两次的羟丁酸盐治疗 [3] - 人为因素研究表明发作性睡病患者能成功遵循LUMRYZ标签上的安全使用说明 [3] - 数据显示LUMRYZ在各种调味液体中按规定剂量溶解情况一致且可接受 [3] - REST - ON临床试验的事后分析表明LUMRYZ治疗可改善发作性睡病患者的白天过度嗜睡和猝倒症状,且不受性别影响 [3] - REST - ON临床试验参与者不同年龄组基线发作性睡病特征比较显示,各年龄组白天过度嗜睡基线测量值相似,年龄较大参与者夜间睡眠中断更严重 [3] - 社交倾听分析表明了解患者经历和自我管理策略有助于睡眠专家更有效识别患者挑战和需求,实现更快诊断和个性化治疗 [3] 会议展示详情 | 日期 | 标题 | 演讲者 | 展示详情 | | --- | --- | --- | --- | | 6月3日 | Composite Response With Once - Nightly Sodium Oxybate: Symptom | Luis Ortiz | Session: P - 13 | | 6月3日 | Stability of Once - Nightly Sodium Oxybate in Alternative Liquid Reconstitution Vehicles | Maggie Lavender | Session: P - 13,Poster Number: 255,Time: 10 - 10:45 a.m. CT | | 6月3日 | Magnitude of Improvement in Excessive Daytime Sleepiness with the Once - at - Bedtime Oxybate for Narcolepsy | John Harsh | Session: P - 13,Poster Number: 261,Time: 10 - 10:45 a.m. CT | | 6月3日 | Comparison of Demographics and Baseline Narcolepsy Symptoms Between Participants with NT1 and NT2 from the Phase 3 REST - ON Clinical Trial | Yves Dauvilliers | Session: P - 13,Poster Number: 262,Time: 11 - 11:45 a.m. CT | | 6月3日 | Efficacy Outcomes Among Male and Female Participant Subgroups: A Post Hoc Analysis from REST - ON | Jennifer Gudeman | Session: P - 13,Poster Number: 250,Time: 11 - 11:45 a.m. CT | | 6月3日 | Assessing Usability of Once - Nightly Sodium Oxybate Extended - Release Oral Suspension for Narcolepsy | Maggie Lavender | Session: P - 13,Poster Number: 252,Time: 11 - 11:45 a.m. CT | | 6月3日 | Consistent Efficacy of Once - Nightly Sodium Oxybate Regardless of Patient Demographic and Baseline Disease Characteristics | Michael Thorpy | Session: P - 13,Poster Number: 258,Time: 11 - 11:45 a.m. CT | | 6月3日 | Patient Preferences of Sodium Oxybate Treatment for Narcolepsy: RESTORE End - of - Study Survey Data | Akinyemi Ajayi | Session: P - 13,Poster Number: 260,Time: 11 - 11:45 a.m. CT | | 6月4日 | Comparison of Baseline Narcolepsy Characteristics Among Participant Age Groups: Analysis From REST - ON Clinical Trial | Thomas Roth | Session: O - 18 (also presented as poster 252),Time: 3:30 - 3:45 p.m. CT | | 6月5日 | Consistent Efficacy of Once - Nightly Sodium Oxybate Regardless of Patient Demographic and Baseline Disease Characteristics | Michael Thorpy | Session: P - 42,Poster Number: 279,Time: 10 - 10:45 a.m. CT | | 6月5日 | Caregiver Preferences for Narcolepsy Treatment: A Discrete Choice Experiment | Luis Ortiz | Session: P - 42,Poster Number: 286,Time: 11 - 11:45 a.m. CT | | 6月5日 | Understanding the Debilitating Nature of Narcolepsy in Patients' Own Words: A Social Listening Analysis | Anne Marie Morse | Session: P - 13,Poster Number: 251,Time: 10 - 10:45 a.m. CT | | 6月5日 | Improvement in Participants With Narcolepsy Type 1 in REST - ON | | Session: P - 13,Poster Number: 253,Time: 10 - 10:45 a.m. CT | [4][5] 公司简介 - 公司是一家生物制药公司,专注于改造药物以改善生活,其商业产品LUMRYZ是首个也是唯一睡前一次服用的羟丁酸盐药物,用于治疗成人发作性睡病的猝倒或白天过度嗜睡症状 [15] 联系方式 - 投资者联系:Courtney Mogerley,Precision AQ,Courtney.Mogerley@precisionaq.com,(212) 698 - 8687 - 媒体联系:Lesley Stanley,Real Chemistry,lestanley@realchemistry.com,(609) 273 - 3162 [19]