Summary: Avadel Pharmaceuticals plc announced the publication of final data from the RESTORE open-label/switch study, which demonstrated a strong preference among people with narcolepsy for the once-nightly Lumryz over a twice-nightly immediate-release oxybate. Lumryz, approved by the FDA in 2023 as the first and only once-nightly oxybate, was overwhelmingly favored by participants for its convenience and improved quality of life.
Key Takeaways:
- Patient Preference for Lumryz: The RESTORE study revealed that 94% of participants preferred the once-nightly Lumryz over the traditional twice-nightly oxybate regimen, citing the convenience of avoiding middle-of-the-night dosing.
- Improved Quality of Life with Lumryz: Participants reported better adherence to medication schedules, improved ability to sleep through the night, and a greater capacity to function during the day without falling asleep after switching to Lumryz.
- Lumryz Well Tolerated and Recommended: The study confirmed Lumryz’s long-term safety and tolerability, with 93% of participants stating they would recommend it to others with narcolepsy, and 79% expressing high satisfaction compared to previous treatments.
Avadel Pharmaceuticals plc announced the publication of final data from the RESTORE open-label/switch study, demonstrating that people with narcolepsy prefer once-at-bedtime Lumryz versus a twice-nightly immediate-release oxybate treatment option.
The US Food and Drug Administration approved Lumryz in 2023 as the first and only once-nightly oxybate. Prior to the approval, twice-nightly oxybates were the only other oxybate options available for more than 20 years.
The paper was published in Sleep Medicine: X.
Initial and end-of-study survey data from RESTORE were previously presented in April 2022 at the American Academy of Neurology Annual Meeting and in June at SLEEP 2024.
“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 Lumryz 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,” says Asim Roy, MD, co-author of the paper, RESTORE investigator, and medical director of the Ohio Sleep Medicine Institute, in a release.
Roy continues, “With Lumryz, 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.”
Phase 3 RESTORE Extension/Switch Study
As part of the multicenter, open-label phase 3 RESTORE extension/switch study, participants with narcolepsy type 1 or 2 who switched from a twice-nightly oxybate to once-nightly Lumryz completed a nocturnal adverse events questionnaire at baseline, a patient preference questionnaire after three months of taking Lumryz, and an end-of-study questionnaire.
These questionnaires showed that:
- Of the 129 switch participants who completed the nocturnal adverse events questionnaire at baseline:
- 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 which they had taken both doses as prescribed.
- More than half (51%) of the 51 participants who took their second nightly oxybate dose more than four hours after the first dose reported feeling somewhat to extremely groggy or unsteady the next morning.
- 92% reported getting out of bed after taking their second dose of oxybate, with 7.5% of those reporting falling after waking up for the second dose, and 4.2% reporting injuries.
- 23% of participants stated they required another person to wake with them in the middle of the night to ensure they took the second dose of their twice-nightly oxybate.
- Of the 98 switch participants who completed the patient preference questionnaire, 94% preferred once-at-bedtime Lumryz to twice-nightly oxybate dosing.
- Of the 68 switch participants who completed the end-of-study questionnaire:
- 79% were very satisfied with Lumryz compared to other narcolepsy treatments they had previously taken.
- 93% would recommend Lumryz to a family member or friend with narcolepsy.
- 91% said they were better able to sleep through the night since starting treatment with Lumryz.
- 91% said they were better able to follow the recommended medication schedule of Lumryz than their previous oxybate.
“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,” says Jennifer Gudeman, PharmD, senior vice president of medical and clinical affairs of Avadel, in a release.
Gudeman continues in a release, “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. 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.”
Photo caption: Lumryz
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