Lumryz Demonstrates Superiority Over Oxybate Treatments in Narcolepsy

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Results from Avadel Pharmaceuticals’ RESTORE study found that patients highly preferred Lumryz (sodium oxybate) over twice-nightly oxybate treatments for narcolepsy. According to the company, 94% of patients with narcolepsy showed a preference toward Lumryz over a twice-nightly oxybate treatment. First approved by the FDA in 2023, Lumryz is currently the only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.¹

“Twice-nightly oxybates can present significant treatment burdens and adherence concerns given the required middle-of-the-night awakening for a second dose. RESTORE study participants overwhelmingly preferred the once-nightly dosing regimen of Lemryz over twice-nightly oxybates. RESTORE further highlighted the inconvenience with the middle-of-the-night dose, as well as the associated grogginess and unsteadiness the following morning if the dose was taken late, and the worsening of symptoms when the dose was missed,” said RESTORE investigator Asim Roy, MD, medical director, Ohio Sleep Medicine Institute, in a press release. “With Lemryz, the majority of switch participants who participated in the survey reported improvements in their ability to get through the day without falling asleep, being better able to sleep through the night, and accomplish more in professional and social settings.”

The Phase III multicenter, open-label extension/switch RESTORE study consisted of patients with narcolepsy type 1 or 2 who switched from a twice-nightly oxybate to once-nightly Lumryz. As part of the study, participants completed a nocturnal adverse events (AEs) questionnaire at baseline, a patient preference questionnaire after three months of taking Lumryz, and an end-of-study questionnaire. A total of 129 individuals completed the nocturnal AE questionnaire, 98 completed the patient preference questionnaire, and 68 completed the end-of-study questionnaire.

Results found that of the 129 people who completed the nocturnal AEs questionnaire, 69% reported missing their second oxybate dose, and of those participants, 80% felt that control of their symptoms was worse the next day compared to days after they had taken both doses as prescribed. Additionally, 51% stated that they felt groggy after taking the second dose of the nightly oxybate, with 92% getting out of bed after taking the second dose and 23% needing somebody to wake them up to take the second dose. End-of-study results found that 79% were satisfied with Lumryz compared to other treatments, 91% stated that they were able to sleep through the night and follow instructions more properly with Lumryz, and 93% stated that they would recommend it to family and friends.

Avadel warns that taking Lumryz with other central nervous system depressants may cause serious medical problems, including trouble breathing, low blood pressure, drowsiness, fainting, and death. Further, it should not be taken in combination with other sleep medications. Patients should wait up to six hours after taking Lumryz to operate heavy machinery until they understand how the treatment affects them.¹

“The RESTORE study, which was conducted for more than three years, allowed investigators switching participants from twice-nightly, first-generation oxybates to understand the myriad challenges associated with chronically taking a middle-of-the-night dose of medication. Nearly 1 out of 4 switch participants reported needing someone else to wake up with them to take the middle-of-the-night dose. Once-at-bedtime Lumryz avoids the dosing burden of a twice-nightly oxybate, which as RESTORE affirms, is experienced in multiple negative aspects for patients, which can be avoided with Lumryz. Not surprisingly, among those switching, more than nine in 10 would recommend Lumryz to a family member or friend with narcolepsy,” said Jennifer Gudeman, PharmD, SVP, medical and clinical affairs, Avadel, in the press release. “Data from RESTORE demonstrate Lumryz was well tolerated, with a low rate of discontinuation due to adverse events, and further confirmed the long-term safety and tolerability of this innovative treatment option.”

Reference

1. Avadel Pharmaceuticals Announces Publication of RESTORE Data Highlighting Challenges with Twice-Nightly Oxybates and Strong Patient Preference for Once-Nightly LUMRYZ™ Dosing (sodium oxybate) Extended-Release Oral Suspension (CIII). Avadel. September 3, 2024. Accessed September 3, 2024. https://investors.avadel.com/news-releases/news-release-details/avadel-pharmaceuticals-announces-publication-restore-data