Avadel Pharmaceuticals Publishes Data on Weight Loss in Narcolepsy Patients Treated with LUMRYZ™

Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical firm dedicated to revolutionizing medical treatments, announced findings from a post-hoc analysis of their completed Phase 3 REST-ON clinical trial. The study revealed significant weight loss among narcolepsy patients treated with LUMRYZ when compared to those receiving a placebo. The detailed results were published in the journal Clinical Therapeutics under the title “Weight Loss With Once-nightly Sodium Oxybate for the Treatment of Narcolepsy: Analysis From the Phase III Randomized study Evaluating the efficacy and SafeTy of a ONce nightly formulation of sodium oxybate (REST-ON) Trial.”

Asim Roy, M.D., co-author of the paper and Medical Director of the Ohio Sleep Medicine Institute, emphasized the obesity concern among narcolepsy patients. Obesity is a crucial modifiable risk factor for cardiovascular diseases. Roy pointed out that the new data indicate LUMRYZ use is linked to reductions in body mass index (BMI) and weight over a 13-week period. Both narcolepsy Type 1 (with cataplexy) and Type 2 (without cataplexy) patients showed improvement in core narcolepsy symptoms, with a marked improvement in those experiencing a weight loss of 5% or more.

The REST-ON trial was a randomized, double-blind, placebo-controlled Phase 3 study assessing the effectiveness of once-nightly LUMRYZ in adults with narcolepsy. Metrics such as weight and BMI were recorded at the start and conclusion of the trial. Participants had an average age of 31.2 years, with 67.9% being women and 75.5% identified as white. At baseline, a substantial portion of participants were overweight or obese: 67.5% of narcolepsy type 1 and 37.0% of narcolepsy type 2 participants in the LUMRYZ group, and 69.5% and 61.0%, respectively, in the placebo group.

Jennifer Gudeman, Pharm.D., Senior Vice President of Medical and Clinical Affairs at Avadel, underscored the significance of these findings given the high rates of obesity in the U.S. and its associated health risks. She noted that nearly 20% of those treated with LUMRYZ achieved clinically meaningful weight loss. Gudeman suggested that LUMRYZ's proven benefits in reducing cataplexy and excessive daytime sleepiness (EDS), along with its once-nightly dosing that allows uninterrupted sleep, could offer a more tailored treatment for overweight or obese individuals with narcolepsy.

The post-hoc analysis highlighted several key findings:

1. Participants treated with LUMRYZ lost an average of 1.3 kg after 13 weeks, while those on placebo gained an average of 0.2 kg.
2. A significantly higher percentage of LUMRYZ-treated participants experienced a weight loss of 5% or more compared to the placebo group (17.8% vs. 3.8%, p=0.001).
3. A notable reduction in BMI was observed after 13 weeks of LUMRYZ treatment compared to placebo, with a difference in least squares mean change from baseline of −0.59 kg/m2 (p=0.001).
4. Participants in the weight loss group transitioned from obese to overweight and from overweight to normal weight, with no participants becoming underweight.

LUMRYZ (sodium oxybate) is an extended-release medication approved by the FDA on May 1, 2023, as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness in adults with narcolepsy. The FDA's approval was based on the REST-ON trial's positive outcomes, demonstrating significant improvements in EDS, overall patient functioning, and cataplexy attacks across evaluated doses compared to placebo. The FDA also granted LUMRYZ seven years of Orphan Drug Exclusivity due to its clinical superiority over existing twice-nightly oxybate products, offering a dosing regimen that prevents nocturnal arousal for a second dose.

Avadel Pharmaceuticals plc continues to focus on creating innovative solutions to address the challenges faced by patients with narcolepsy, providing more effective and convenient treatment options like LUMRYZ.