Avadel Pharmaceuticals will present new data supporting the clinical profile for Lumryz (sodium oxybate) for extended-release oral suspension and patient preference for a once-nightly oxybate in 12 abstracts at SLEEP 2023.
Lumryz (previously known as FT218), is an extended-release formulation of sodium oxybate indicated to be taken once at bedtime for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.
Lumryz was granted US Food and Drug Administration (FDA) approval in May, and is the first and only FDA-approved once-at-bedtime oxybate for people living with narcolepsy. Lumryz also was granted Orphan Drug Exclusivity, as the Office of Orphan Product Development identified Lumryz to be clinically superior to immediate-release oxybates based upon the major contribution to patient care that Lumryz provides by way of its once-nightly dosing, according to a release from Avadel.
“We are thrilled to attend SLEEP 2023 and present a broad range of data further supporting the clinical value proposition of Lumryz as a once-nightly option to manage EDS and cataplexy in narcolepsy, including data from our RESTORE and REST-ON trials,” says Jennifer Gudeman, PharmD, senior vice president, medical and clinical affairs at Avadel, in a release. “Additionally, presentations at this year’s conference also include insights gleaned from MyNarcolepsyTeam, where people with narcolepsy reported the need for relief from both daytime and nighttime symptoms. With final approval of Lumryz, we’re proud to offer the narcolepsy community a once-at-bedtime treatment option for cataplexy or excessive daytime sleepiness that removes the burden of twice-nightly dosing and provides the opportunity for an uninterrupted night’s sleep.”
Lumryz has a boxed warning as a central nervous system depressant and for its potential for abuse and misuse. Lumryz is available only through a restricted program under a Risk Evaluation and Mitigation Strategy called the Lumryz REMS.
Highlights from the presentations include:
- An oral presentation demonstrating that treatment with Lumryz at all tested doses in the completed pivotal phase 3 REST-ON clinical resulted in clinically significant improvement in EDS and cataplexy according to American Academy of Sleep Medicine-established criteria.
- Two posters with results from an online survey given to US members of the MyNarcolepsyTeam, a social network of approximately 10,000 members living with narcolepsy, where patients reported experiencing an initial under-diagnosis or misdiagnosis with a disorder other than narcolepsy and an extreme or very severe impact of narcolepsy on daily life, as well as experiencing and seeking relief from both daytime and nighttime symptoms and needing multiple medications to address both symptoms.
- Two oral presentations and one poster with interim analyses from the ongoing RESTORE open-label extension/switch study of Lumryz, showing: patient preference for once-nightly dosing of Lumryz and high treatment burden with twice-nightly immediate-release oxybate; that Lumryz is generally well-tolerated with few patients discontinuing due to adverse reactions; and successful titration of Lumryz to a therapeutic and tolerable dose within one month.
- Post-hoc analyses reinforcing positive data from the REST-ON in one oral presentation and two posters, demonstrating greater weight loss and improvements in cataplexy and EDS in patients who received Lumryz compared with placebo.
Presentation details are as follows:
|Title||Session||Presenter||Date and Time|
|Oral Presentations (also available as posters)|
|Patient Preferences and Nocturnal Experiences With Oxybate Therapy for Narcolepsy: RESTORE Study Interim Analysis||O-04P-35, poster #316||John Harsh||June 5|
10:30 – 10:45 am ET
|Characterization of Patients with Narcolepsy Treated vs Not Treated with Sodium Oxybate: A Propensity Score-Matched Cohort Study||O-04P-35, poster #318||Melissa Lipford||June 5|
10:45 – 11 am ET
|Long-Term Safety of Once-Nightly Oxybate for Narcolepsy: RESTORE Study Interim Analysis of Data||O-31P-35, poster #315||John Harsh||June 7|
3:15 – 3:30 pm ET
|Sodium Oxybate Treatment Patterns in Narcolepsy Patients: A Propensity Score–Matched Cohort Study Subanalysis||O-31P-35, poster #317||Lois Krahn||June 7|
3:30 – 3:45 pm ET
|Cataplexy Response With FT218 (Once-Nightly Sodium Oxybate): Post Hoc Responder Analysis From the Phase 3 Rest-ON Clinical Trial||O-31P-35, poster #319||Michael Thorpy||June 7|
3:45 – 4 pm ET
|Application of AASM Clinical Significance Thresholds to Once-Nightly Sodium Oxybate for Improvement in Narcolepsy Symptoms||O-31P-35, poster #320||Thomas Roth||June 7|
4 – 4:15 pm ET
|Path to Diagnosis and Impact of Narcolepsy on Quality of Life: A Survey of People Living With Narcolepsy||P-13, poster #233||Anne Marie Morse||June 5|
12 – 1:15 pm ET
|Demographic Characteristics and Comorbidities of Patients with Narcolepsy: A Propensity Score-Matched Cohort Study||P-13, poster #232||Melissa Lipford||June 5|
5 – 6 pm ET
|Understanding Narcolepsy Treatments From the Patient’s Perspective: A Survey of People Living With Narcolepsy||P-13, poster #244||Matthew Horsnell||June 5|
5 – 6 pm ET
|Characterization of Patients Who Had ≥5% Weight Loss With FT218 (Once-Nightly Sodium Oxybate): Post Hoc Analysis From REST-ON||P-35, poster #229||Thomas Roth||June 6|
5 – 6 pm ET
|Dose Titration of Once-Nightly Sodium Oxybate: Analysis of Interim Data From RESTORE||P-35, poster #283||Jennifer Gudeman||June 6|
5 – 6 pm ET
|Improvement in Sleep Latency With FT218 (Once-Nightly Sodium Oxybate): Analysis From the Phase 3 REST-ON Clinical Trial||P-35, poster #300||Maurice Ohayon||June 6|
5 – 6 pm ET
In addition to Avadel’s oral and poster presentations, the company will support a symposium titled “Addressing Unmet Medical Needs and Introduction of LUMRYZ, a New Narcolepsy Treatment” on Tuesday, June 6, 11:45 am – 12:45 pm ET.
The symposium will feature panel presentations from Anne Marie Morse, DO, director of child neurology and pediatric sleep medicine at Geisinger Medical Center at Janet Weis Children’s Hospital; Yves Dauvilliers, MD, PhD, director of the Sleep and Wake Disorders Centre in the department of neurology at the Gui de Chauliac Hospital in Montpellier, France; Michael J. Thorpy, MD, director of the Sleep-Wake Disorders Center at Montefiore and professor of neurology at Albert Einstein College of Medicine; and Clete Kushida, MD, PhD, division chief and medical director of Stanford Sleep Medicine, neurologist and professor in the department of psychiatry and behavioral sciences at Stanford University Medical Center, and director of the Stanford Center for Human Sleep Research at Stanford University.
In addition, the panel will include a person with narcolepsy, enrolled in the open-label RESTORE study since September 2020, who will speak about her clinical trial experience.