Summary: Avadel Pharmaceuticals plc announced the publication of a post-hoc analysis from the completed phase 3 REST-ON clinical trial, which evaluated the effects of Lumryz, an extended-release sodium oxybate, on weight and body mass index (BMI) in adults with narcolepsy. The trial’s findings, published in Clinical Therapeutics, reveal that participants treated with Lumryz experienced greater weight loss compared to those receiving a placebo. The results suggest that Lumryz may offer a tailored treatment approach for people with narcolepsy who are overweight or obese, in addition to its established benefits in reducing cataplexy and excessive daytime sleepiness.
Key Takeaways:
- Significant Weight Loss Observed: Participants treated with Lumryz during the 13-week REST-ON trial lost an average of 1.3 kg, while those on placebo gained an average of 0.2 kg. Additionally, a significantly higher proportion of Lumryz-treated participants achieved a ≥5% weight loss compared to the placebo group (17.8% versus 3.8%).
- BMI Reduction in Lumryz Group: The trial demonstrated a significant reduction in BMI among Lumryz-treated participants, with a between-group difference of −0.59 kg/m² compared to the placebo group. This BMI reduction was clinically meaningful, with participants shifting from obese to overweight and from overweight to normal weight categories.
- Potential for Tailored Treatment: Lumryz, approved by the FDA as the first once-at-bedtime treatment for cataplexy or excessive daytime sleepiness in adults with narcolepsy, may provide additional benefits for patients struggling with obesity—a common issue among those with narcolepsy—by contributing to weight loss and improved BMI alongside symptom management.
Avadel Pharmaceuticals plc announced the publication of results of a post-hoc analysis from the completed phase 3 REST-ON clinical trial demonstrating greater weight loss in patients who received Lumryz compared with placebo.
The paper was published online in Clinical Therapeutics.
“Obesity is a struggle for many people, and it is very common in patients with narcolepsy,” says Asim Roy, MD, co-author of the paper and medical director of the Ohio Sleep Medicine Institute, in a release. “Obesity is an important modifiable risk factor for cardiovascular diseases. These new data show that Lumryz use was associated with a reduction in body mass index and weight during the 13-week trial.”
REST-ON is a randomized, double-blind, placebo-controlled, pivotal phase 3 trial evaluating once-at-bedtime Lumryz in adults with narcolepsy. Weight and body mass index (BMI) were measured at baseline and at the end of the study. The mean age of the study participants was 31.2 years. 67.9% were women, and 75.5% were white.
Among those treated with Lumryz (n=107), 67.5% and 37.0% of participants with narcolepsy type 1 and narcolepsy type 2, respectively, were overweight or obese at baseline, as were 69.5% and 61.0%, respectively, of those in the placebo group (n=105). Mean weight at baseline was similar between the Lumryz and placebo groups (81.2 kg and 82.1 kg, respectively).
REST-ON Trial Findings
“Given the high rates of obesity in the US, and its associated cardiometabolic risks, we were encouraged to see that nearly one in five study participants treated with Lumryz experienced clinically meaningful weight loss,” says Jennifer Gudeman, PharmD, senior vice president of medical and clinical affairs of Avadel, in a release. “These findings suggest that Lumryz, given its proven benefit in reducing cataplexy and [excessive daytime sleepiness], as well its once-at-bedtime dosing, which provides the opportunity for an uninterrupted night sleep, has the potential to provide a more tailored treatment approach for people with narcolepsy who are overweight or living with obesity.”
Results of the post-hoc analysis, which evaluated the effect of Lumryz treatment on weight in adults with narcolepsy and further characterized participants experiencing >5% weight loss, showed:
- Participants who received Lumryz lost a mean of 1.3 kg from baseline to week 13. In contrast, those receiving placebo experienced a mean weight gain of 0.2 kg.
- A significantly higher proportion of study participants receiving Lumryz experienced ≥5% weight loss than those who received placebo (17.8% versus 3.8%; p=0.001).
- A significant reduction in BMI was observed after 13 weeks of treatment with Lumryz versus placebo, with a between-group difference in least squares mean change from baseline of −0.59 kg/m2 (p=0.001).
- In the weight loss group, participants shifted from obese into overweight, and from overweight into normal weight during this trial; no participants were underweight.
“While all REST-ON participants, including both narcolepsy Type 1 (with cataplexy) and narcolepsy Type 2 (without cataplexy) showed improvement in core narcolepsy symptoms (i.e., excessive daytime sleepiness and cataplexy), this improvement was even more pronounced in the subgroup experiencing a ≥5% weight loss,” says Roy in a release.
Lumryz, an extended-release sodium oxybate medication, was approved by the US Food and Drug Administration on May 1, 2023, as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness in adults with narcolepsy.
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