Avadel Pharmaceuticals plc announced new and encore data abstracts emphasizing the clinical benefit of Lumryz (sodium oxybate) and patient preference for a once-at-bedtime narcolepsy treatment option at World Sleep 2023.
The company will present 15 poster presentations and two oral presentations. Lumryz is a US Food and Drug Administration (FDA)-approved 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.
“Quality sleep is a foundational pillar of health for people with narcolepsy, yet ~65% of patients with narcolepsy experience poor, fragmented sleep in addition to their daytime symptoms. Lumryz is the only FDA-approved oxybate treatment that provides clinically proven symptom improvement for excessive daytime sleepiness (EDS) or cataplexy while its novel once-at-bedtime formulation removes the need for forced awakenings to take a middle-of-the-night oxybate dose,” says Jennifer Gudeman, PharmD, senior vice president of medical and clinical affairs of Avadel, in a release.
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.
Highlights from the presentations include:
- Post-hoc analyses reinforcing data from the completed pivotal phase 3 REST-ON trial, demonstrating that treatment with Lumryz resulted in statistically significant and clinically meaningful improvement in EDS as measured by the Epworth Sleepiness Scale, a patient-reported outcome, with the median score in the range considered normal at the end of the study.
- A poster from the open-label RESTORE study demonstrating long-term tolerability and clinically significant improvement in symptoms, including EDS, cataplexy, nighttime awakenings, and severity of narcolepsy, with Lumryz, providing insight into its real-world use.
- Two posters including new post-hoc analyses that demonstrate the robust clinical efficacy of Lumryz and provide further insight into the improvements on measures of EDS and cataplexy compared with placebo in different demographic and clinical subgroups based on age, sex, race, body mass index, narcolepsy subtype, and alerting agent use.
- A poster presenting demographic differences between patients with narcolepsy subtypes NT1 (with cataplexy) and NT2 (without cataplexy), with data from objective measures of EDS showing identical sleep latency, comparable subjective assessments of sleep quality and refreshing nature of sleep, with some other baseline parameters suggestive of more severe disease in NT1.
- A poster with results from a survey of people living with narcolepsy describing their significant daytime and nighttime symptoms and primary focus on the treatment of daytime symptoms in discussions between clinicians and patients, highlighting the need for comprehensive discussion and understanding of the full range of symptoms experienced by people with narcolepsy.