{"id":829361,"date":"2025-03-25T08:05:26","date_gmt":"2025-03-25T12:05:26","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/avadel-announces-publications-in-cns-drugs-supplement-highlighting-key-clinical-issues-for-people-with-narcolepsy-and-their-clinicians\/"},"modified":"2025-03-25T08:05:26","modified_gmt":"2025-03-25T12:05:26","slug":"avadel-announces-publications-in-cns-drugs-supplement-highlighting-key-clinical-issues-for-people-with-narcolepsy-and-their-clinicians","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/avadel-announces-publications-in-cns-drugs-supplement-highlighting-key-clinical-issues-for-people-with-narcolepsy-and-their-clinicians\/","title":{"rendered":"Avadel Announces Publications in CNS Drugs Supplement Highlighting Key Clinical Issues for People with Narcolepsy and Their Clinicians"},"content":{"rendered":"
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DUBLIN, March 25, 2025 (GLOBE NEWSWIRE) — Avadel Pharmaceuticals plc\u00a0(Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today announced the publication of six manuscripts covering clinical management, shared decision-making and goal setting for people with narcolepsy and their clinicians in a CNS Drugs <\/em>supplement<\/a> titled \u201cA New Dawn in the Management of Narcolepsy\u201d.<\/p>\n

\u201cI am delighted to serve as guest editor for the recently published CNS Drugs<\/em> supplement, focused on key clinical issues for people with narcolepsy and their clinicians with a particular emphasis on sodium oxybate therapy, an underutilized treatment option,\u201d said Michael J. Thorpy, M.D., an investigator for the Phase 3 REST-ON trial of LUMRYZ\u2122, Director at the Sleep-Wake Disorders Center at\u00a0Montefiore Medical Center\u00a0and Professor of Neurology at the\u00a0Albert Einstein College of Medicine. \u201cThis supplement provides clinicians with important information about how to optimize therapy to help address narcolepsy symptoms, including new analyses of onset of efficacy and practical considerations for use of a once-nightly sodium oxybate therapy, to enable clinicians to set proper expectations when initiating LUMRYZ therapy.\u201d<\/p>\n

\n Summary of Papers in <\/strong>
\n
\n CNS Drugs <\/em>
\n <\/strong>
\n Supplement<\/strong>\n <\/p>\n\n\n\n\n\n\n\n\n
\n Paper Title<\/strong>\n <\/td>\n\n Authors\/Synopsis<\/strong>\n <\/td>\n<\/tr>\n
\n Narcolepsy: Beyond the Classic Pentad<\/a>\n <\/td>\nAuthored by Anne Marie Morse, D.O., Director of Pediatric Neurology at Geisinger Medical Center and others, this paper addresses the full 24-hour impact and symptom burden that patients experience, as well as the need for an individualized treatment approach and care considerations that extend beyond the hallmark features of the disease.<\/td>\n<\/tr>\n
\n A Survey of People Living With Narcolepsy in the USA: Path to Diagnosis, Quality of Life, and Treatment Landscape From the Patient\u2019s Perspective<\/a>\n <\/td>\nAuthored by Luis E. Ortiz, M.D., Assistant Professor of Pediatrics at Johns Hopkins Medicine and others, the survey reports data from 110 people living with narcolepsy. Among the key findings: nearly three-fourths (72%) of respondents experienced some form of nighttime sleep disturbance (such as disrupted nighttime sleep and fragmented sleep) and approximately one-third (33%) of sodium oxybate users reported their top treatment goal was medicine to help them sleep through the night.<\/td>\n<\/tr>\n
\n Therapeutic Use of \u03b3-Hydroxybutyrate: History and Clinical Utility of Oxybates and Considerations of Once and Twice-Nightly Dosing in Narcolepsy<\/a>\n <\/td>\nAuthored by Thomas Roth, Ph.D., founder of the Sleep Disorders and Research Center at Henry Ford Health, this paper provides a 50-year historical overview of \u03b3-Hydroxybutyrate (GHB) use in narcolepsy, including more than two decades of safe and appropriate use as a treatment. The paper also includes data on changes to sleep architecture that occur during treatment with LUMRYZ, aligning with a more \u201cnormal\u201d sleep pattern in people with narcolepsy vs. chronic middle-of-the-night awakening.<\/td>\n<\/tr>\n
\n Assessing Early Efficacy After Initiation of Once-Nightly Sodium Oxybate (ON-SXB; FT218) in Participants With Narcolepsy Type 1 or 2: A Post Hoc Analysis From the Phase 3 REST-ON Trial<\/a>\n <\/td>\nAuthored by Lois E. Krahn, M.D., Professor of Psychiatry at the Mayo Clinic College of Medicine and others, this analysis demonstrates significant improvements in certain narcolepsy symptoms (including sleep quality and refreshing nature of sleep) with LUMRYZ versus placebo one to two weeks after treatment initiation, with increasing improvement from week 3 onward.<\/td>\n<\/tr>\n
\n Efficacy of Once-Nightly Sodium Oxybate in Patients With Narcolepsy: Post Hoc Analyses of Sensitivity, Effect Size, and Numbers Needed to Treat From the Phase 3 REST-ON Trial<\/a>\n <\/td>\nAlso authored by Dr. Roth and others, this paper provides further validation of the robust efficacy once-nightly LUMRYZ demonstrated in the REST-ON trial across primary and secondary endpoints.<\/td>\n<\/tr>\n
\n Sodium Oxybate: Practical Considerations and Patient Perspectives<\/a>\n <\/td>\nAuthored by Maggie Lavender, M.S.N., of Comprehensive Sleep Medicine Associates in Houston, Texas and others, this paper includes illustrative clinical case scenarios of two people with narcolepsy, providing clinicians with a proposed framework to optimize discussions with patients and demystify sodium oxybate treatment, providing practical tips and support for initiating and maintaining therapy.<\/td>\n<\/tr>\n<\/table>\n

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\u201cDespite sodium oxybate being FDA-approved for more than two decades and strongly recommended by the American Academy of Sleep Medicine for nearly 20 years, this therapy remains underutilized \u2013 in part due to the historical burdensome dosing for first-generation oxybates. The title of this supplement, A New Dawn in the Management of Narcolepsy, reflects that the patient community no longer needs to accept the status quo,\u201d said Jennifer Gudeman, Pharm.D., Senior Vice President, Medical and Clinical Affairs of Avadel.<\/p>\n

\u201cThese publications illustrate the impact of nighttime sleep disturbances on narcolepsy patients, highlight the robust data supporting LUMRYZ, and perhaps most importantly, demystify oxybate therapy, with a particular focus on LUMRYZ initiation and maintenance of therapy,\u201d continued Dr. Gudeman. \u201cPatients taking once-nightly LUMRYZ may experience transient tolerability effects, coupled with some degree of symptom relief after one to two weeks and increasing improvement from week three onward, which may help clinicians set expectations with patients to improve medication adherence.\u201d<\/p>\n

\n About LUMRYZ\u2122\u00a0(sodium oxybate) for extended-release oral suspension\u00a0<\/strong>
\n
LUMRYZ is an extended-release sodium oxybate medication approved by the FDA on\u00a0May 1, 2023, as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.\u202f\u202fOn October 16, 2024, LUMRYZ was additionally approved as a once-at-bedtime treatment for cataplexy or EDS in patients 7 years of age and older with narcolepsy.<\/p>\n

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, clinicians\u2019 overall assessment of patients\u2019 functioning (CGI-I) and cataplexy attacks, for all three evaluated doses when compared to placebo.<\/p>\n

With its approval, the FDA also granted seven years of Orphan Drug Exclusivity to LUMRYZ for the treatment of cataplexy or EDS in adults with narcolepsy 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 to patient care over currently available, twice-nightly oxybate products by providing a once-nightly dosing regimen that avoids nocturnal arousal to take a second dose. A second 7-year period of Orphan Drug Exclusivity was granted with the approval of the expanded indication in October 2024.<\/p>\n

\n INDICATIONS<\/strong>
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LUMRYZ\u00a0(sodium oxybate) for extended-release oral suspension is a prescription medicine used to treat the following symptoms in patients 7 years of age and older with narcolepsy:<\/p>\n