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Jessica Langbaum, PhD, the senior director of research strategy at Banner Alzheimer’s Institute, discussed the challenges and opportunities in improving diversity in Alzheimer disease clinical trials.

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Clinical

 Narcolepsy Disease Spotlight page offers specific updates and coverage on the latest expert conversations and data readouts related to the treatment and management of patients with the sleep disorder.

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 podcast features exclusive interviews with leaders in the field discussing the latest research and disease management strategies across the breadth of neurology, including epilepsy, multiple sclerosis (MS), Parkinson disease, dementia, sleep disorders, and more.

This episode, "FDA Approves Sodium Oxybate for Pediatric Narcolepsy," features an exclusive interview with Anne Marie Morse, DO, FAASM, a pediatric sleep disorders specialist, who sat down to discuss the significance of the FDA's expanded indication for sodium oxybate (Lumryz; Avadel Pharmaceuticals) for the treatment of pediatric patients aged 7 years and older with narcolepsy. Morse, director of Child Neurology and Pediatric Sleep Medicine at Geisinger Janet Weis Children's Hospital as well as the program director for Child Neurology Residency Program, provided commentary on the clinical considerations behind this once-nightly formulation of sodium oxybate, and how it should be used going forward. Furthermore, she stressed the careful use of sodium oxybate treatments, noting that they may have significant impact on patients with narcolepsy and should not be only reserved for the most severe cases.

For more of NeurologyLive's coverage of sodium oxybate's expanded approval, head here: 

FDA Approves Avadel's Sodium Oxybate for Cataplexy or Excessive Daytime Sleepiness in Pedatric Narcolepsy

 – Immediate reaction and significance 

 – Considerations and caution with prescribing sodium oxybate

 – Closing remarks and the need to utilize highly effective treatments for narcolepsy

 podcast. Be sure to leave a rating and review for the show. Thanks for listening!

REFERENCES
1. Avadel Pharmaceuticals Announces FDA Approval of LUMRYZ™ (sodium oxybate) Extended-Release Oral Suspension (CIII) for the Treatment of Cataplexy or Excessive Daytime Sleepiness in Patients 7 Years of Age and Older with Narcolepsy. News Release. Avadel Pharmaceuticals. Published October 17, 2024. Accessed October 23, 2024. https://investors.avadel.com/news-releases/news-release-details/avadel-pharmaceuticals-announces-fda-approval-lumryztm-sodium

Mind Moments®, a podcast from NeurologyLive®, brings you an exclusive interview with Anne Marie Morse, DO, FAASM. [LISTEN TIME: 12 minutes]

Special Episode: FDA Approves Sodium Oxybate for Pediatric Narcolepsy

The Mind Moments podcast features exclusive interviews with leaders in the field discussing the latest research and disease management strategies across the breadth of neurology, including epilepsy, multiple sclerosis, Parkinson disease, dementia, sleep disorders, and more.

In this episode, "Understanding the Potential Cardiovascular Benefits of Low-Sodium Oxybate," Phil Jochelson, MD, therapeutic head for Clinical Development Neuroscience at Jazz Pharmaceuticals, sat down to discuss the phase 4 XYLO study, a randomized controlled study evaluating the effects of switching from high-sodium to low-sodium oxybate on blood pressure in patients with narcolepsy. Jochelson gave some insight regarding the conduct of the trial, including end points, objectives, and patient demographics, as well as some of the benefits to studying blood pressure and cardiovascular risks. In addition, he discussed enhancements to narcolepsy care through low-sodium oxybate, the importance of unique studies like XYLO, and the need to educate clinicians on sodium load and its risks.

The stories featured in this week's Neurology News Minute, which will give you quick updates on the following developments in neurology, are further detailed here:

EU Regulatory Review Adopts Negative Opinion of Lecanemab as Treatment for Alzheimer Disease

GLP-1 Agonist Liraglutide Shows Protective Effects on Alzheimer Disease in Phase 2 Trial

FDA Approves Carbidopa/Levodopa ER Capsules Formulation IPX203 for Parkinson Disease

 – Reasons behind the XYLO study and links between high sodium intake and cardiovascular risk

 – Patient demographics; inclusion and exclusion criterias

 – Overview of XYLO and determining what a successful study looks like

 – Improved understanding of the benefits of low-sodium oxybate

 to subscribe to the Mind Moments podcast. Be sure to leave a rating and review for the show. Thanks for listening!

Hoping to listen on your favorite podcast app? See below:

Mind Moments®, a podcast from NeurologyLive®, brings you an exclusive interview with Phil Jochelson, MD. [LISTEN TIME: 20 minutes]

Episode 121: Understanding the Potential Cardiovascular Benefits of Low-Sodium Oxybate

Episode 110, "Differential Diagnosis of Sleep Disorders and Hypersomnias" features a conversation with Alcibiades Rodriguez, MD, medical director of the Comprehensive Epilepsy Center—Sleep Center at NYU Langone, who discussed several sleep-related topics, including the diagnosis of rare sleep disorders and hypersomnias. He spoke on the treatment of obstructive sleep apnea, the importance of adherence to medication, and the ways clinicians can help patients stick to their treatment regimen. Furthermore, he talked about the conversations between patients and clinicians to ensure an accurate diagnosis, as well as the emerging research in the sleep disorder field over the coming years.


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 – Conversations needed to differentiate diagnoses

 – Appearance of sleep disorders and overlap

 – Complications with untreated sleep apnea

 – Ways to improve adherence to medication

Mind Moments®, a podcast from NeurologyLive®, brings you an interview with Alcibiades Rodriguez, MD. [LISTEN TIME: 19 minutes]

Episode 110: Differential Diagnosis of Sleep Disorders and Hypersomnias

Episode 104, "Effects of Once-Nightly Sodium Oxybate on Narcolepsy Types 1 and 2" features an interview with Jennifer Gudeman, PharmD, senior vice president of medical and clinical affairs for Avadel Pharmaceuticals, who discussed a recently published post-hoc analysis of the phase 3 REST-ON trial of once-nightly sodium oxybate (Lumryz). In the conversation, Gudeman talked about the impact of the drug on both narcolepsy types 1 and 2, the differences between these 2 subtypes, and the ways clinical trials of narcolepsy agents continue to evolve. Furthermore, she spoke on some of the unmet needs for this patient population, including lingering brain fog and overcoming negative stigmas.

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FDA Clears NeuroOne’s OneRF Ablation System for Neurosurgerical Procedures

 – Overview of post-hoc analysis of REST-ON

– Differences in type 1 and 2 narcolepsy

– Expanding treatment profile of once-nightly sodium oxybate

– Lingering unmet needs of patients with narcolepsy

 – Realistic timeline of gene therapies for epilepsy

– Future of narcolepsy research, drug development trials

Mind Moments®, a podcast from NeurologyLive®, brings you an exclusive interview with Jennifer Gudeman, PharmD. [LISTEN TIME: 17 minutes] 

Episode 104: Effects of Once-Nightly Sodium Oxybate on Narcolepsy Types 1 and 2

Episode 98, "Uncovering Phenotypical Features of Narcolepsy Type 1" Features an interview with Birgitte R. Kornum, MD, an associate professor in the department of neuroscience at the University of Copenhagen, who discussed recently published preclinical research assessing phenotypical features and disease progression of narcolepsy type 1. Kornum provided insight on the 2 mouse models used, the effectiveness of the DVC System, and some of the phenotypic features identified. In addition, she gave insight on how the research adds to the ongoing puzzle of treating narcolepsy and where future efforts should be directed toward.

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 – Overview of Medicare study and objectives

 – Clinical takeaways from the findings

 – Critical phenotypic features of narcolepsy 

 – Significance of this research, future goals

Mind Moments®, a podcast from NeurologyLive®, brings you an exclusive interview with Birgitte Kornum, MD. [LISTEN TIME: 18 minutes]

Episode 98: Uncovering Phenotypical Features of Narcolepsy Type 1

Episode 91, "Assessing the Landscape of Sleep Disorder Care," features an exclusive interview with Ann Marie Morse, DO, FAAN, a pediatric neurologist and sleep medicine specialist at Geisinger Medical Center, who sat down with us at the annual SLEEP meeting to discuss the landscape of challenges narcolepsy-related challenges that patients face, the influence of gut health on sleep apnea, and much more.

Biogen and Denali Terminate Phase 3 LIGHTHOUSE Study of BIIB122 in LRRK2-related Parkinson Disease

FibroGen's Duchenne Muscular Dystrophy Antibody Pamrevlumab Falls Short in Phase 3

Phase 2/3 Study of Blarcamesine in Pediatrics With Rett Syndrome Completes Enrollment

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FDA Panel Votes in Favor of Eisai’s Lecanemab for Early Alzheimer Disease

Post-Marketing Study of Andexanet Alfa Stopped Early After Achieving Prespecified Efficacy

 – Factors at play in obstructive sleep apnea

 – Literature on the gut microbiome's role in sleep

 – Lingering needs in narcolepsy treatment

 – The effect of disrupted nighttime sleep

Mind Moments®, a podcast from NeurologyLive®, brings you an exclusive interview with Ann Marie Morse, DO, FAAN. [LISTEN TIME: 20 minutes]

Episode 91: Assessing the Landscape of Sleep Disorder Care

 podcast features exclusive interviews with leaders in the field discussing the latest research and disease management strategies across the breadth of neurology, including epilepsy, multiple sclerosis, Parkinson disease, dementia, sleep disorders, and more.

Episode 85, "Impact of Narcolepsy on Social Relationship Health in Adolescents," features an exclusive interview with Eric Zhou, PhD, assistant professor of pediatrics at Harvard Medical School. He spoke on a recently conducted study assessing the link between narcolepsy in adolescents and social relationship health. Specifically, he talked about how the sleep disorder impacts mood, physical activities, driving, and other long-term health outcomes, as well as ways we can help adolescents with narcolepsy at the earliest stages.

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 – Identified links between narcolepsy and social relationships

 – Long-term impacts of affected mood, physical activities, and driving 

 – Current assessment of narcolepsy in adolescents

 – Attempts to prevent narcolepsy at earliest stages

 – Implementing programs in school to help adolescents with narcolepsy

 – Future research on narcolepsy in younger populations

REFERENCE
1. Zhou ES, Revette A, Heckler GK, Worhach J, Maski K, Owens JA. Building a deeper understanding of social relationship health in adolescents with narcolepsy disorder. 

. 2023;19(3):491-498. doi:10.5664/jcsm.10372

Mind Moments®, a podcast from NeurologyLive®, brings you an exclusive interview with Eric Zhou. [LISTEN TIME: 14 minutes]

Episode 85: Impact of Narcolepsy on Social Relationship Health in Adolescents

In a previously completed phase 1 study, the treatment resulted in significant improvements in wakefulness at doses of 1.0 mg and 2.5 mg, prompting a follow-up study.

New Phase 2 Study to Test Orexin Receptor 2 Agent ORX750 in Various Sleep Disorders

The director of Child Neurology and Pediatric Sleep Medicine at Geisinger Janet Weis Children's Hospital talked about how the recent approval of once-nightly sodium oxybate for pediatric narcolepsy enables more effective and manageable treatment options for children and families.

NeuroVoices: Anne Marie Morse, DO, FAASM, on the Impact of the Once-Nightly Sodium Oxybate Approval  for Pediatric Narcolepsy 

Sodium oxybate is the only FDA-approved once-at-bedtime treatment for cataplexy or excessive daytime sleepiness in pediatric patients with narcolepsy.

In the phase 1 trial, the 2.5 mg dose of ORX750 significantly improved wakefulness, restoring normal sleep latency to 32 minutes compared to placebo.

Centessa to Advance Orexin Agent ORX750 to Phase 2 Studies Following Positive Interim Data

Vibrance-2 is a double-blind, placebo-controlled trial with 80 participants, assessing three doses of ALKS 2680 over eight weeks

Alkermes Initiates Phase 2 Study of Orexin Receptor Agent ALKS 2680 in Narcolepsy Type 2

Anne Marie Morse, DO, FAASM, provided her immediate reaction to the approval of a once-nightly sodium oxybate for pediatric narcolepsy.

Understanding the Approval of Once-Nightly Sodium Oxybate for Pediatric Narcolepsy: Anne Marie Morse, DO, FAASM

"This monumental day moves the needle forward, allowing us to treat every patient more effectively, not just some."

 (Lumryz; Avadel Pharamaceuticals) for cataplexy or excessive daytime sleepiness in adults with narcolepsy.

 The approval was supported by data from the phase 3 REST-ON trial (NCT02720744) which showed a significantly greater increase in sleep latency with sodium oxybate treatment at week 3 for the 6-g dose group (8.1 vs 3.1 min, respectively; least-squares mean difference [LSMD], 4.98; 95% CI, 2.90-7.05; 

The director of Child Neurology and Pediatric Sleep Medicine at Geisinger Janet Weis Children's Hospital provided her immediate reaction to the approval of a once-nightly sodium oxybate for pediatric narcolepsy. [WATCH TIME: 7 minutes]

Narcolepsy

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