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Articles

The committee all agreed that tofersen presents a favorable risk-benefit profile in this particularly challenging patient population. 

FDA AdComm on Tofersen Supports NfL as Surrogate End Point of Clinical Benefit, But Is It Enough for Approval?

After results indicated significant slowing of ALS disease progression, Coya noted it plans to file an IND with the FDA in the second half of 2023 for a potential clinical study thereafter.

Treg Suppressing Agent COYA 302 Shows Slowing of ALS Disease Progression

If approved, ABBV-951 will become the first subcutaneous delivery of carbidopa/levodopa, often considered the standard of care for symptom management for patients with Parkinson disease.

FDA Issues Complete Response Letter for AbbVie’s 24-Hour Continuous Carbidopa/Levodopa Pump

The professor of neurology and pediatrics at University of Rochester Medical Center shared her thoughts on the 2023 MDA Clinical and Scientific Conference, and the progress made in the treatment of neuromuscular disorders. 

NeuroVoices: Emma Ciafaloni, MD, on Mounting Progress in the Neuromuscular Field, Duchenne Muscular Dystrophy

The neurologist and migraine expert from NYU Langone Health.

Videos

The neurologist and migraine expert from NYU Langone Health shared her reactions to the recently approved zavegepant nasal spray (Zavzpret; Pfizer) for the treatment of migraine. [WATCH TIME: 5 minutes]  

Newly Approved Migraine Nasal Spray Offers Alternative Treatment to Injections, Oral Medications: Shae Datta, MD

Slideshows

Here's the latest multidisciplinary MS research published online first in the International Journal of MS Care.

IJMSC Online First: March 2023

Director, Comprehensive Epilepsy Center, NYU Langone Health

The director of the Comprehensive Epilepsy Center at NYU Langone discussed the importance of healthy eating habits and whether all individuals with epilepsy should consider dieting early in their life. [WATCH TIME: 4 minutes]

Importance of Establishing Healthy Eating Habits in Epilepsy: Orrin Devinsky, MD

The vascular neurologist at Cleveland Clinic provided an overview of a study that assessed the extent HbA1c impacts the relationship between mechanical thrombectomy and poor outcomes. [WATCH TIME: 3 minutes]

Effect of HbA1c Elevation, Glycemic Control Following Mechanical Thrombectomy: David Baker, DO

The sleep medicine center is a comprehensive resource for clinical news on the diagnosis, treatment, and management of sleep. | NeurologyLive.


Sleep Medicine | Clinical Neurology News & Insights | NeurologyLive

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1.125rem

Clinical

 clinical focus page on sleep disorders provides information about the latest FDA actions, clinical guideline updates, clinical trial findings, and interviews with physicians on conditions such as obstructive sleep apnea, cataplexy, narcolepsy, insomnia, excessive daytime sleepiness, and more. The page features podcasts, videos, and news stories about the latest in clinical care for these sleep disorders.

's featured content in the carousel below.

 to subscribe on your favorite streaming service.

 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 74, "Prescription Digital Therapeutics for Insomnia," features an exclusive interview with Yuri Maricich, MD, MBA, internal medicine physician, and chief medical officer and head of development, Pear Therapeutics. He joined the show to discuss the current use of digital therapeutics in insomnia such as cognitive behavioral therapy, the state of education and treatment for the sleep disorder, some of the challenges in care, and more.

. Check out new episodes of a variety of shows, airing every single day, only on

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:

Alzheimer Disease Agent Lecanemab Shows Reduction in CDR-Sum of Boxes in Clarity AD

Verdiperstat Fails to Differentiate From Placebo in Critical HEALEY ALS Platform Trial

AMX0035 Approved for the Treatment of ALS

CNM-Au8 Shows Survival Benefit in HEALEY ALS Trial, But Fails to Meet End Points

Episode Breakdown

 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:

REFERENCES
1. Forma F, Knight TG, Thorndike FP, et al. Real-World Evaluation of Clinical Response and Long-Term Healthcare Resource Utilization Patterns Following Treatment with a Digital Therapeutic for Chronic Insomnia. 

. 2022;14:537-546. doi:10.2147/CEOR.S368780

Disease Spotlight: Insomnia

Mind Moments®, a podcast from NeurologyLive®, brings you an exclusive interview with Yuri Maricich, MD, MBA. [LISTEN TIME: 30 minutes]

Episode 74: Prescription Digital Therapeutics for Insomnia

Episode 71, "Pediatric Sleep and School Start Times," features an exclusive interview with Chris Winter, MD, owner of Charlottesville Neurology and Sleep Medicine clinic and CNSM Consulting, and an author of several books on sleep. He shared his perspective on the state of pediatric sleep disorders, how the current system of schooling affects children's sleep, and the trends that are occurring in sleep research.

Two Patient Deaths Reported With Zolgensma Administration in SMA

Passage Bio Doses First Patient in Frontotemporal Dementia Gene Therapy Trial

BLA Application to Be Submitted for ALS Agent NurOwn Following Phase 3 Statistical Corrections

Jazz Initiates Trial Assessing Cannabidiol in Epilepsy With Myoclonic-Atonic Seizures

Mind Moments®, a podcast from NeurologyLive®, brings you an exclusive interview with Chris Winter, MD. [LISTEN TIME: 31 minutes]

Episode 71: Pediatric Sleep and School Start Times

Episode 66, "2022 SLEEP Annual Meeting Highlights," features interviews with a number of individuals who presented data and spoke at the American Academy of Sleep Medicine's SLEEP Annual Meeting, on topics ranging from the examination of longitudinal patterns of difficulty initiating sleep and their associations with subsequent memory trajectories among different races and genders, JZP-258’s impact on the treatment of patients with idiopathic hypersomnia, and the understanding of the signs and risks associated with sleep disorders and Alzheimer disease.

. Check out new episodes every Tuesday and Thursday only on

Afsara Zaheed, graduate student, University of Michigan

Richard Bogan, MD, FCCP, FAASM, associate clinical professor, University of South Carolina School of Medicine, and associate clinical professor, 

Ruth Benca, MD, PhD, professor and chair, Psychiatry & Human Behavior, Wake Forest School of Medicine

Click here for more coverage of SLEEP 2022.

Mind Moments®, a podcast from NeurologyLive®, brings you exclusive interviews with Afsara Zaheed; Richard Bogan, MD, FCCP, FAASM; and Ruth Benca, MD, PhD. [LISTEN TIME: 18 minutes]

Episode 66: 2022 SLEEP Annual Meeting Highlights

 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.

Episode 59, "AASM's Push to End Daylight Saving Time," features an exclusive interview with Seema Khosla, MD, FCCP, FAASM, medical director, North Dakota Center for Sleep. She shared her insight into the American Academy of Sleep Medicine's ongoing initiative to switch to a fixed standard time year-round, as well as offered her perspective on the current state of care for sleep disorders.

The stories highlighted in this episode's Neurology News Minute can be found here:

Roche Announces Phase 3 SKYLINE Trial of Gantenerumab in Alzheimer Disease

FDA Approves Saluda’s Evoke Spinal Cord Stimulation System for Chronic Intractable Pain

IND Application Accepted for Phase 2b Trial of NOE-101 in Trigeminal Neuralgia

REFERENCES
1. Rishi MA, Ahmed O, Perez JHB, et al. Daylight saving time: an American Academy of Sleep Medicine position statement. 

. 2020;16(10):1781-1784. doi:10.5664/jcsm.8780
2. AASM calls for end of seasonal time changes ahead of “springing forward”. News release. AASM. March 9, 2022. Accessed March 10, 2022. https://aasm.org/aasm-calls-for-end-of-seasonal-time-changes-ahead-of-springing-forward/

Mind Moments®, a podcast from NeurologyLive®, brings you an exclusive interview with Seema Khosla, MD, FCCP, FAASM. [LISTEN TIME: 29 minutes]

Episode 59: AASM's Push to End Daylight Saving Time

This episode, "Daridorexant Approved for Insomnia," features an exclusive interview with Thomas Roth, PhD, director, Sleep Disorders and Research Center, Henry Ford Hospital; professor of psychiatry, Wayne State University School of Medicine; and clinical professor of psychiatry, University of Michigan College of Medicine. Roth, who was an investigator in the clinical development studies of the newly approved Idorsia therapy, offered insight into the known efficacy and safety profiles, as well as some context to its potential impact on the therapeutic landscape of insomnia.

's coverage of daridorexant's approval here

REFERENCES
Idorsia receives US FDA approval of Quviviq (daridorexant) 25 and 50 mg for the treatment of adults with insomnia. News release. Idorsia. January 10, 2022. Accessed January 10, 2022. https://www.biospace.com/article/releases/idorsia-receives-us-fda-approval-of-quviviq-daridorexant-25-and-50-mg-for-the-treatment-of-adults-with-insomnia/?s=85

Mind Moments®, a podcast from NeurologyLive®, brings you an exclusive interview with Thomas Roth, PhD. [LISTEN TIME: 12 minutes]

Special Episode: Daridorexant Approved for Insomnia

Episode 54, "The Shortage of Neurologists," features an exclusive interview with Jennifer Majersik, MD, MS, chief, division of vascular neurology, and professor of neurology, University of Utah, who along with 9 other colleagues, authored a report from the American Academy of Neurology (AAN) 2019 Transforming Leaders Program on the ongoing shortage of physicians in neurology. She offered her perspective on the challenge and how it can be addressed from an individual and institutional level.

REFERENCES
Majersik JJ, Ahmed A, Chen IA, et al. A shortage of neurologists – we must act now: A report from the AAN 2019 transforming leaders program. 

. Published online April 30, 2021. doi:10.1212/WNL.0000000000012111

Mind Moments®, a podcast from NeurologyLive®, brings you an exclusive interview with Jennifer Majersik, MD, MS.

Episode 54: The Shortage of Neurologists

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 (MS), Parkinson disease, dementia, sleep disorders, and more.

Episode 51, "The State of Sleep Medicine," features an exclusive interview with Karl Doghramji, MD, FAASM, DFAPA, professor of psychiatry and human behavior; professor of neurology; and medical director, Jefferson Sleep Disorders Center, at the 

Vickie and Jack Farber Institute for Neuroscience of Jefferson Health

. He shared his perspective on the current state of care for sleep disorders, the impact of the pandemic on sleep in the US, and some of the recent advances in therapeutics and research.

Phase 3 PHOENIX Study of AMX0035 in ALS Gets Under Way

FDA Approves First Oral Solution of Topiramate to Treat Epilepsy, Migraines

Robert Califf, MD, Nominated by Biden Administration as Next FDA Commissioner

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

Mind Moments™, a podcast from NeurologyLive®, brings you an exclusive interview with Karl Doghramji, MD, FAASM, DFAPA.

Episode 51: The State of Sleep Medicine

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.

Episode 42, "The Importance of Sleep in Overall Health," features an exclusive interview with Raman Malhotra, MD, associate professor of neurology, Washington University in St. Louis, and president, American Academy of Sleep Medicine (AASM). He discussed the AASM's recent position statement calling for a greater emphasis on sleep health in education, clinical practice, inpatient and long-term care, public health promotion, and the workplace due to sleep's critical role in overall health. He also shared insight into the impact the COVID-19 pandemic has had on sleep and the Healthy People 2030 initiative that the AASM is taking part in.

This episode also features a new segment, the Neurology News Minute, which will give you quick updates on the following developments in neurology:

NIH Awards Funding to Study RNS System in Lennox-Gastaut Syndrome

FDA Commissioner Calls for Independent Review of Agency Interactions on Aducanumab

Novel SUDEP-3 Inventory Shows Potential to Predict SUDEP Risk

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

REFERENCE
Ramar K, Malhotra RK, Carden KA, et al. Sleep is essential to health: an American Academy of Sleep Medicine position statement. Published online June 21, 2021. doi: 10.5664/jcsm.9476

"Mind Moments," a podcast from NeurologyLive, brings you an exclusive interview with Raman Malhotra, MD.

Episode 42: The Importance of Sleep for Overall Health

Episode 40, "SLEEP 2021: Topline Data, Telemedicine, and Takeaways," features an interview with Michael J. Thorpy, MD, director, Sleep-Wake Disorders Center, Montefiore Medical Center, and professor of neurology, Albert Einstein College of Medicine. He shared his takeaways from the recent SLEEP 2021 meeting, his perspective on the investigational narcolepsy agent FT218, the current pipeline for excessive daytime sleepiness and cataplexy, the pandemic’s impact on sleep care.

Montefiore Health System

"Mind Moments," a podcast from NeurologyLive, brings you an exclusive interview with Michael J. Thorpy, MD.

Episode 40: SLEEP 2021: Topline Data, Telemedicine, and Takeaways

Episode 30, "Cognitive Behavioral Therapy for Insomnia," features an interview with Jennifer Martin, PhD, professor of medicine, University of California-Los Angeles, and a board member of the American Academy of Sleep Medicine (AASM), to discuss the AASM's recent 

—of which she was a coauthor—that recommends the use of multi-component cognitive behavioral therapy for the treatment of insomnia.

"Mind Moments," a podcast from NeurologyLive, brings you an exclusive interview with Jennifer Martin, PhD.

Episode 30: Cognitive Behavioral Therapy for Insomnia

Here's some of what is coming soon to NeurologyLive® this week.

This Week on NeurologyLive® — March 20, 2023

Anne Marie Morse, DO, a pediatric neurologist and sleep medicine specialist at Geisinger Medical Center, talked about the challenges that adolescents with narcolepsy face in their social relationships. 

A Balancing Challenge: Social Relationships in the Life of Adolescents With Narcolepsy 

Mechanistically, reboxetine and a combination of reboxetine and oxybutynin improved pharyngeal collapsibility and respiratory control.

Reboxetine Reduces Respiratory Events, Improves Obstructive Sleep Apnea Severity

In honor of World Sleep Day, held March 17, 2023, get caught up on some of the latest news in sleep disorders as the NeurologyLive® team shares some of our data updates.

Neuro News Roundup: World Sleep Day 2023

Take 5 minutes to catch up on NeurologyLive®'s highlights from the week ending March 17, 2023.

NeurologyLive® Friday 5 — March 17, 2023

“In summary, this adds hope to some of the 40 million patients in the United States who suffer from migraines, the second leading cause of disability. This approval will help us control migraines in patients better if they have injection phobia, don't want to take pills, or don't remember to take their pills or bring it with them.”

 nasal spray, a calcitonin gene-related peptide (CGRP) receptor antagonist, for the acute treatment of migraine with or without aura in adults. The therapy, marketed as Zavzpret, is the first and only CGRP nasal spray available for patients with migraine, expected to be available to pharmacies starting in July 2023.

The nasal spray is a third-generation, high-affinity, selective and structurally unique agent that had its 

 by 2 pivotal double-blind, placebo-controlled studies.

In the first trial (NCT03872453), zavegepant 10- and 20-mg doses were more effective than placebo on the coprimary end points of pain freedom at 2 hours postdose (placebo: 15.5% [98.3% CI, 11.1, 19.8]; 10 mg: 22.5% [98.3% CI, 17.5, 27.6]; 

 = .0113; 20 mg: 23.1% [98.3% CI, 18.1, 28.2]; 

 = .0055) and freedom from the most bothersome symptom (MBS) at 2 hours postdose (placebo: 33.7% [98.3% CI, 28.0, 39.3]; 10 mg: 41.9% [98.3% CI, 36.0, 47.9]; 

 = .0155; 20 mg: 42.5% [98.3% CI, 36.6, 48.4]; 

 Then, in the second trial (NCT04571060), not only were the coprimary end points of pain freedom (24% vs 15%; 

<.0001) and freedom from MBS (40% vs 31%; 

= .0012) achieved, but the treatment showed statistically significant differences relative to placebo across a total of 15 prespecified primary and secondary outcome measures.

Shae Datta, MD, neurologist and migraine expert from 

to provide her clinical perspective on the approval and what it means for patients with migraines

 In addition, Datta, who is codirector of the NYU Langone concussion center, talked about the supporting data from the trials and the significance of the findings.

REFERENCES
1. Pfizer’s Zavzpret (zavegepant) migraine nasal spray receives FDA approval. News release. Pfizer. March 10, 2023. Accessed March 17, 2023. https://www.businesswire.com/news/home/20230309005795/en/Pfizer%E2%80%99s-ZAVZPRET%E2%84%A2-zavegepant-Migraine-Nasal-Spray-Receives-FDA-Approval
2. Biohaven achieves positive topline results in pivotal phase 2/3 study of vazegepant, the first and only intranasal CGRP receptor antagonist in clinical development for the acute treatment of migraine. News release. December 17, 2019. Accessed March 17, 2023. https://www.prnewswire.com/news-releases/biohaven-achieves-positive-topline-results-in-pivotal-phase-23-study-of-vazegepant-the-first-and-only-intranasal-cgrp-receptor-antagonist-in-clinical-development-for-the-acute-treatment-of-migraine-300976000.html
3. Lipton RB, Croop R, Stock DA, et al. Safety, tolerability, and efficacy of zavegepant 10 mg nasal spray for the acute treatment of migraine in the USA: a phase 3, double-blind, randomized, placebo-controlled multicentre trial. 

2023;22(3):209-217. doi:10.1016/S1474-4422(22)00517-8

SAP Partners

In this program, sleep experts will discuss the importance of timely and accurate diagnosis, recent approvals and available treatment options for the management of narcolepsy and excessive daytime sleepiness.

Advances in the Management of Excessive Daytime Sleepiness and Narcolepsy

Welcome to this special edition of Neurology News Network. I’m Marco Meglio.

Findings from a small-scale, longitudinal study assessing patients with narcolepsy with cataplexy showed that after 3 years of treatment with low to medium doses of sodium oxybate, there were 

significant differences in sleep structure

Neurology News Network for the week ending February 26, 2022. [WATCH TIME: 3 minutes]