"LUMRYZ's novel once-nightly delivery system means patients do not have to worry about not waking up and missing their second dose. The single bedtime dose helps assure patients receive the full therapeutic benefit of their medication every night, demonstrated in the REFRESH study to result in clinically meaningful outcomes for both switch and naïve oxybate patients,” said Gerard J. Meskill, MD, CEO of Tricoastal Narcolepsy and Sleep Disorders Center. “It also means their partners don't have to wake up to an alarm, which is a forgotten burden of this disease and can be a source of guilt for patients."
Additional highlights from the presentations at World Sleep 2025 include:
- Updated and new results from an interim descriptive analysis of data from REFRESH (n=51), a prospective multicenter, real-world study in patients with narcolepsy, including those who switched to LUMRYZ from twice-nightly and those new to oxybate or returning to oxybate after discontinuing twice-nightly oxybate.
- Results showed that participants experienced clinically meaningful improvements in Epworth Sleepiness Scale (ESS) scores, a measure of excessive daytime sleepiness (EDS), to within the normal range.
- REFRESH study participants experienced a reduction in severity from moderate at the start of the study to mild at study end for the pentad of narcolepsy symptoms measured on the Narcolepsy Severity Scale (NSS) and reduced interference across domains on the Sheehan Disability Scale (SDS).
- After completing 4 months of therapy (switch participants, n=20; non-switch, n=31), 70% and 76% of switch participants and 90% and 87% of non-switch participants were improved on the Patient Global Impression of Change and the Clinician Global Impression of Change, respectively.
- Additional interim results from a study questionnaire and end of study survey showed that overall quality of life, fatigue, brain fog, depression, anxiety, and mood improved and as-needed use of stimulants was reduced.
- To characterize the comorbidities of patients with narcolepsy, an analysis of aggregate patient data from electronic health records (EHR) was conducted at Duke University. Results from 1,659 patients with narcolepsy and 1,659 matched controls showed sleep, pain and psychiatric or mood disorders occurred significantly more frequently in patients with narcolepsy versus the control group (all p<0.0001); hypertension and cardiovascular disease were not included in the top 23 comorbidities identified to be increased.
“Presentations at this year’s World Sleep congress reinforce the benefits of LUMRYZ, including improvements in the hallmark symptoms of EDS, disrupted nighttime sleep, and sleep-related hallucinations,” said Jennifer Gudeman, Pharm.D., Senior Vice President, Medical and Clinical Affairs of Avadel. “In particular, the emerging data from the REFRESH study provide further evidence of symptom improvement with LUMRYZ. While the magnitude of change was greatest for those not on an oxybate at study entry, meaningful improvements were also observed in the twice-nightly oxybate switch cohort showing additional clinical benefit that can be gained by consistently taking a single, full therapeutic dose of oxybate at bedtime.”
About LUMRYZ™ (sodium oxybate) for extended-release oral suspension
LUMRYZ is an extended-release sodium oxybate medication approved by the FDA on May 1, 2023, as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. On October 16, 2024, LUMRYZ was additionally approved as a once-at-bedtime treatment for cataplexy or EDS in pediatric patients seven years of age and older with narcolepsy.
The FDA approval of LUMRYZ was supported by results from REST-ON™, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial in adults with narcolepsy. LUMRYZ demonstrated statistically significant and clinically meaningful improvements in the three co-primary endpoints: EDS (MWT), clinicians’ overall assessment of patients’ functioning (CGI-I), and cataplexy attacks, for all three evaluated doses when compared to placebo.
With its approvals in May 2023 and October 2024, the FDA also granted seven years of Orphan Drug Exclusivity to LUMRYZ for the treatment of cataplexy or EDS in adults with narcolepsy and in pediatric patients seven years of age and older with narcolepsy respectively due to a finding of clinical superiority of LUMRYZ relative to currently available oxybate treatments. In particular, the FDA found that LUMRYZ makes a major contribution to patient care over currently available, twice-nightly oxybate products by providing a once-nightly dosing regimen that avoids nocturnal arousal to take a second dose.
LUMRYZ is only currently approved for the treatment of cataplexy or EDS in patients seven years of age and older with narcolepsy, and Avadel does not sell LUMRYZ for any indication beyond narcolepsy.
INDICATIONS:
- LUMRYZ (sodium oxybate) for extended-release oral suspension is a prescription medicine used to treat the following symptoms in patients seven years of age and older with narcolepsy:
- sudden onset of weak or paralyzed muscles (cataplexy)
excessive daytime sleepiness (EDS)
LUMRYZ can cause serious side effects, including the following:
- Breathing problems, including slower breathing, trouble breathing and/or short periods of not breathing while sleeping (e.g., sleep apnea). People who already have breathing or lung problems have a higher chance of having breathing problems when they take LUMRYZ.
- Mental health problems, including confusion, seeing or hearing things that are not real (hallucinations), unusual or disturbing thoughts (abnormal thinking), feeling anxious or upset, depression, thoughts of killing yourself or trying to kill yourself, increased tiredness, feelings of guilt or worthlessness and difficulty concentrating. Tell your doctor if you or your child have or had depression or have tried to harm yourself. Call your doctor right away if you or your child have symptoms of mental health problems or a change in weight or appetite.
- Sleepwalking. Sleepwalking can cause injuries. Call your doctor if you or your child start sleepwalking.
Tell your doctor if you or your child are on a salt-restricted diet or have high blood pressure, heart failure or kidney problems. LUMRYZ contains a lot of sodium (salt) and may not be right for you.
The most common side effects of LUMRYZ in adults include nausea, dizziness, bedwetting, headache and vomiting. Your side effects may increase when you take higher doses of LUMRYZ. The most common side effects in children include nausea, bedwetting, vomiting, headache, decreased weight, decreased appetite, dizziness, and sleepwalking.
LUMRYZ can cause physical dependence and craving for the medicine when it is not taken as directed. These are not all the possible side effects of LUMRYZ.
About Avadel Pharmaceuticals plc
Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company focused on transforming medicines to transform lives. Our approach includes applying innovative solutions to the development of medications that address the challenges patients face with current treatment options. Avadel’s commercial product, LUMRYZ, was approved by the U.S. Food & Drug Administration (FDA) as the first and only once-at-bedtime oxybate for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy.
For more information, please visit www.avadel.com.
