This series of bite-sized episodes will take you through the latest information regarding disrupted nighttime sleep and its relationship to cardiovascular risk, plus patient/clinician preferences regarding the treatment of narcolepsy with sodium oxybates.
Oxybates: 1 Molecule, 3 Formulations – Efficacy
Oxybates: 1 Molecule, 3 Formulations – Efficacy
Welcome to CME on ReachMD. This episode is part of our MinuteCME curriculum.
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This is CME on ReachMD, and I’m Dr. Michael Thorpy. Here with me today is Dr. Clete Kushida.
There have been now 3 forms of oxybate that have been approved for the treatment of narcolepsy. There was a recently approved medication, which is a once-nightly formulation.
Clete, can you give us an overview of the clinical trial data regarding the efficacy of the 3 oxybate formulations?
Yes. Thank you, Michael. So first I’ll talk about Xyrem, and for Xyrem, there’s been a number of double-blind, placebo-controlled, multicenter, parallel-group trials, as well as some randomized withdrawal trials, and they have looked at endpoints such as frequency of cataplexy attacks and both subjective and objective daytime sleepiness. And for all those endpoints, there has been statistically significant improvement for those measures.
The next formulation that I’m going to be talking about is Xywav, which is the low-sodium formulation of sodium oxybate. And for that, there’s also been a few trials. Most recently is a placebo-controlled, double-blind, randomized withdrawal study in 134 adults with narcolepsy with cataplexy that was published in 2021 by Bogan. And what that study showed was that there was efficacy of this low-sodium oxybate preparation for the frequency of cataplexy attacks as well as excessive daytime sleepiness by the Epworth Sleepiness Scale.
Now lastly, I want to be talking about Lumryz, which is the once-nightly formulation, and for that particular study there’s been most recently a study of 212 patients that were randomized to receive Lumryz versus placebo, and it was studied in a double-blind, randomized, placebo-controlled, two-arm, multicenter study to assess both the efficacy and safety of Lumryz. And there were 3 co-primary endpoints. One was the objective Maintenance of Wakefulness Test, second was Clinical Global Impression Improvement measure, and the last was the mean change in weekly cataplexy attacks. And across all those primary endpoints there was a significant improvement compared to placebo in all those measures.
Thank you, Clete, for that overview. So we have these 3 formulations of oxybate that can be used for narcolepsy, and as you have indicated, they are efficacious for not only the excessive daytime sleepiness but also the cataplexy, and the overall patient impression is very high with regards to these agents. In addition to their treating cataplexy and sleepiness, we also know that the oxybate tends to improve nighttime sleep, as these agents are generally given at night. And typically, they’ve been given in twice-nightly doses, but now with this new Lumryz, as you mentioned, it’s a once-nightly formulation. So that holds some advantages for some patients, that they only need to take the medication when they go to bed and not in the middle of the night.
Well, this has been a great bite-sized discussion. Unfortunately, our time is up. Thanks for listening.
You have been listening to CME on ReachMD. This activity is provided by Prova Education and is part of our MinuteCME curriculum.
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In accordance with the ACCME Standards for Integrity and Independence, Global Learning Collaborative (GLC) requires that individuals in a position to control the content of an educational activity disclose all relevant financial relationships with any ineligible company. GLC mitigates all conflicts of interest to ensure independence, objectivity, balance, and scientific rigor in all its educational programs.
Michael J. Thorpy, MD
Director, Sleep‐Wake Disorders Center
Montefiore Medical Center
Professor of Neurology, Albert Einstein College of Medicine
Consulting/Advisory Board: Alkermes, Avadel Pharmaceuticals, Axsome, Balance Therapeutics, Eisai Pharmaceuticals, Harmony Biosciences, LLC, Idorsia Pharmaceuticals, Jazz Pharmaceuticals, NLS Pharmaceuticals, Suven Life Sciences Ltd., Takeda Pharmaceutical Co., Ltd, XW Pharma
Clete A. Kushida, MD, PhD
Professor, Division Chief
Medical Director, Sleep Medicine
Stanford University School of Medicine
Consulting Fees: XW Pharma
Research: Avadel Pharmaceuticals
Ann Marie Morse, DO
Director, Child Neurology and Pediatric Sleep Medicine
Geisinger Medical Center
Janet Weis Children’s Hospital
Consulting Fees: Alkermes, Avadel Pharmaceuticals, Jazz Pharmaceuticals, Harm Reduction Therapeutics, Takeda Pharmaceutical Co.
Research: Geisinger Health Plan, Jazz Pharmaceuticals, NIH, UCB,
Other: Damm Good Sleep, LLC
Franz H. Messerli, MD
Professor of Medicine
University of Bern
No relevant relationships reported.
- Jennifer Brutsche has nothing to disclose.
- Cindy Davidson has nothing to disclose.
- Elizabeth Lurwick has nothing to disclose.
- Andrea Mathis has nothing to disclose.
- Tim Person has nothing to disclose.
- Robert Schneider, MSW, has nothing to disclose.
- Peer Review, if applicable, Brian P. McDonough, MD, FAAFP, has nothing to disclose.
After participating in this educational activity, participants should be better able to:
- Evaluate the efficacy and safety of available sodium oxybate therapies in improving outcomes for patients with narcolepsy
- Describe the quality-of-life impact and potential cardiovascular effects of disrupted nighttime sleep on patients with narcolepsy
- Compare and contrast various federal and medical society guidelines, as well as clinical trial data, as to what constitutes appropriate sodium intake
- Define the counseling processes by which patients and clinicians can communicate about goals of treatment and implement shared decision-making as to the therapeutic management approach
This activity is designed to meet the educational needs of sleep medicine specialists, psychiatrists, and neurologists.
In support of improving patient care, Global Learning Collaborative (GLC) is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.
Global Learning Collaborative (GLC) designates this enduring activity for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Global Learning Collaborative (GLC) designates this activity for 1.0 nursing contact hour. Nurses should claim only the credit commensurate with the extent of their participation in the activity.
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This activity is supported by an independent educational grant from Avadel Pharmaceuticals.
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