Avadel will present a series of new analyses highlighting the efficacy, safety, and patient preference for Lumryz, a once-nightly, extended-release formulation of sodium oxybate.

Summary: At SLEEP 2024, Avadel will present new data on Lumryz, the first extended-release, once-nightly formulation of sodium oxybate for narcolepsy. Findings highlighted patient preference for Lumryz over twice-nightly oxybate, with 94% preferring once-nightly dosing and reporting better sleep. Data showed Lumryz consistently improved excessive daytime sleepiness and cataplexy regardless of age or gender. Patient usability studies demonstrated they could follow Lumryz’s instructions. Additional data covered Lumryz’s stability in various liquids, a social media analysis on patient experiences, and a product theater featuring expert perspectives on evolving narcolepsy care with once-nightly Lumryz.

Key Takeaways: 

• Avadel will present multiple new analyses on its recently approved drug Lumryz at the SLEEP 2024 annual meeting. Lumryz is the first and only extended-release formulation of sodium oxybate that allows once-nightly dosing for treating narcolepsy symptoms like cataplexy and excessive daytime sleepiness.
• The data highlighted patient satisfaction and preference for the once-nightly Lumryz compared to twice-nightly oxybate products. A study found 94% of patients who switched preferred the once-nightly dosing, with 91% reporting better sleep through the night on Lumryz.
• Other data showed Lumryz provided consistent improvement in narcolepsy symptoms like excessive daytime sleepiness and cataplexy regardless of patient demographics like age and gender. Patient usability studies also demonstrated narcolepsy patients could successfully follow Lumryz’s instructions.

Avadel Pharmaceuticals plc will present 11 posters and one oral presentation supporting the use of Lumryz as a narcolepsy treatment option at SLEEP 2024 in Houston.

Approved by the US Food and Drug Administration (FDA) in 2023, Lumryz is the first and only extended-release formulation of sodium oxybate and indicated to be taken once at bedtime for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy.

“Presentations at this year’s SLEEP 2024 add to our increasing collection of data on Lumryz as an effective and preferred narcolepsy treatment option for patients to help improve their daytime symptoms of narcolepsy without disrupting sleep for a second middle-of-the-night dose,” says Jennifer Gudeman, PharmD, senior vice president of medical and clinical affairs of Avadel, in a release.

Gudeman continues in a release, “Part of our presentations will underscore new patient preference findings from our RESTORE study, revealing that in addition to previously reported data which showed that 94% of patients who switched from a twice-nightly oxybate stated a preference for once-nightly dosing, 91% of study participants reported they were better able to sleep through the night with Lumryz, and 89% of participants would recommend Lumryz to a family or friend with narcolepsy.”

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. The most common adverse reactions (incidence >5% and greater than placebo) reported for all doses of Lumryz combined were nausea, dizziness, enuresis, headache, and vomiting.

Presentation Highlights

Highlights from the presentations of new data presented at the meeting include:

• End-of-study survey data from the RESTORE open-label/switch study demonstrating that patients experienced a high level of satisfaction with once-at-bedtime Lumryz, including improved symptom control, an improvement in dosing adherence and a preference for Lumryz over twice-nightly oxybate treatment options.
• Findings from a human factor study revealing that individuals with narcolepsy, regardless of their prior experience with oxybate treatment, can successfully follow the label instructions for safe use of Lumryz.
• Data showing consistent and acceptable dissolution of Lumryz at prescribed doses in various flavored liquids, which may be preferred by some patients as alternatives to water.
• Post hoc analysis from Avadel’s completed pivotal REST-ON clinical trial that showed treatment with Lumryz improved symptoms of EDS and cataplexy in people with narcolepsy regardless of gender.
• A poster comparing baseline narcolepsy characteristics among three age groups (youngest: 16–25 years of age; middle: 26–34 years of age; oldest: 35–72 years of age) of participants from the REST-ON clinical trial which indicated that baseline measures of EDS were similar among age groups. Additionally, objective data from polysomnography showed worse disrupted nighttime sleep (DNS) in older participants, indicating DNS may worsen with age.
• Findings from a social listening analysis of content posted on MyNarcolepsyTeam, a social network for people with narcolepsy, which concluded that gaining a better understanding of patient experiences and self-management strategies enables sleep specialists to more effectively identify challenges and needs of patients, leading to quicker diagnoses and tailored treatments.

Presentation Details

All abstracts have been published in an online supplement in the journal Sleep. Presentation details are as follows:

Additionally, Avadel will host a product theater for US healthcare professionals titled, “Evolving narcolepsy care: expert perspectives on Lumryz, the first and only once-at-bedtime sodium oxybate,” on Tuesday, June 4, at 11:45 am CT at the George R. Brown Convention Center. 

The symposium will feature Maggie Lavender, MSN, APRN, FNP-C, of Comprehensive Sleep Medicine Associates, Michael J. Thorpy, MD, director of the Sleep-Wake Disorders Center at Montefiore and Professor of Neurology at Albert Einstein College of Medicine, and a person with narcolepsy.