Avadel Pharmaceuticals Presents New Data on LUMRYZ ER at SLEEP 2025

 Avadel Pharmaceuticals plc, a biopharmaceutical company focused on transforming medicines to transform lives, today announced that new data supporting the use of LUMRYZ as a narcolepsy treatment and additional data to better understand the real-life experience of people living with narcolepsy will be presented in four oral presentations and 14 posters at SLEEP 2025, the 39^th Annual Meeting of the Associated Professional Sleep Societies (APSS), taking place June 8-11, 2025 in Seattle.

“Post-hoc analysis of the pivotal Phase 3 REST-ON clinical trial, restricted to those study participants with the most severe sleepiness at baseline as measured both objectively and subjectively, showed LUMRYZ participants with a median Epworth Sleepiness Scale (ESS) score at Week 13 that was improved to the range at or below that considered normal. Another post-hoc investigation analyzed the apnea-hypopnea index (AHI) for those with no or mild sleep apnea at baseline and provides reassuring data that the AHI was not worsened at any LUMRYZ dose,” said Richard Bogan, M.D., lead study author, Medical Director of SleepMed of South Carolina and Associate Clinical Professor at both the University of South Carolina School of Medicine and the Medical University of South Carolina.

“In addition, and importantly, an interim analysis of narcolepsy patients in an open-label switch study, REFRESH, from twice-nightly to once-nightly oxybate therapy, demonstrated clinically significant efficacy and improvement of excessive daytime sleepiness. The REFRESH study is an additional piece of evidence validating the efficacy of LUMRYZ in the treatment of excessive sleepiness and cataplexy in narcolepsy patients.”

Highlights from the presentations at SLEEP 2025 include:

• Interim REFRESH results demonstrating that among 67 patients (approximately half oxybate naïve, 37% switches from twice-nightly oxybates, and the remainder previous twice-nightly oxybate users); patients in all groups achieved clinically significant reductions in sleepiness, with normal ESS scores after starting LUMRYZ.
• A post-hoc analysis restricted to the most severely sleepy tertiles at baseline in REST-ON; at the end of the study, median ESS was at or below the normal threshold with LUMRYZ.
• A post-hoc analysis from REST-ON to quantify hypnagogic and hypnopompic hallucinations (HH) during the trial; these aggregate data show that LUMRYZ participants reported approximately half as many HH events where they felt like they were going to be attacked, flying through the air, or falling into a hole compared to placebo.
• A post-hoc analysis from REST-ON demonstrating consistency of LUMRYZ efficacy across objective and subjective disrupted nighttime sleep outcomes in various subgroups (e.g., narcolepsy type 1 or 2, male or female, stimulant use).
• A retrospective chart analysis of patients with sleep-related eating disorder (SRED) while on twice-nightly oxybates, which was ameliorated after switching to LUMRYZ.
• A post hoc analysis from the stable dosing period of the RESTORE open-label study evaluating 115 participants (median treatment: 503 days) who switched from twice-nightly oxybate to LUMRYZ; side effects were consistent with the known adverse events of oxybates and only 4% of participants discontinued LUMRYZ due to a treatment-related adverse event, underscoring the long-term tolerability of LUMRYZ.
• A survey conducted in collaboration with MyNarcolepsyTeam of 88 respondents, revealing the need for enhanced patient-clinician discussions of oxybates as a treatment option, as well as better setting of oxybate treatment expectations to minimize discontinuations, particularly as they relate to side effects that are generally transient in nature.

“We are thrilled with our strong scientific presence at SLEEP 2025 and the opportunity to further enhance awareness and understanding of the benefits that LUMRYZ offers to people living with narcolepsy,” said Jennifer Gudeman, Pharm.D., Senior Vice President, Medical and Clinical Affairs of Avadel. “I am particularly excited that there will be data available on SRED, a phenomenon that has been shown to disproportionately impact people taking immediate-release, twice-nightly oxybate,¹ and which Dr. Lewis Kass describes in his practice as resolving when his patients transitioned to LUMRYZ. Additionally, our interim REFRESH data not only demonstrate efficacy, with patients achieving ESS scores in the normal range, they also further corroborate prior research of frequent missed middle-of-the-night doses with twice-nightly oxybates and diminished efficacy when this occurs.”^2,3

All abstracts were published in an online supplement in the journal Sleep.

Source: Avadel