Avadel announces results of post-hoc analysis on Phase 3 REST-ON trial

Avadel Pharmaceuticals announced the publication of results of a post-hoc analysis from the completed pivotal Phase 3 REST-ON clinical trial demonstrating greater weight loss in patients who received LUMRYZ compared with placebo. The paper, titled “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 Trial,” was published online in Clinical Therapeutics. Results of the post-hoc analysis, which evaluated the effect of LUMRYZ treatment on weight in adults with narcolepsy and further characterized participants experiencing greater than5% 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 greater than or equal to5% weight loss than those who received placebo. 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. In the weight loss group, participants shifted from obese into overweight, and from overweight into normal weight during this trial; no participants were underweight.