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Atul Malhotra, Kingman P Strohl, Lawrence P Carter, Michelle Baladi, Lawrence Lee, Shay Bujanover, Michael J Thorpy, 0618 Weight Change Associated with Solriamfetol Treatment of Excessive Daytime Sleepiness in Participants with Narcolepsy or Obstructive Sleep Apnea, Sleep, Volume 42, Issue Supplement_1, April 2019, Page A246, https://doi.org/10.1093/sleep/zsz067.616
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Abstract
Solriamfetol is a dopamine and norepinephrine reuptake inhibitor with demonstrated efficacy in treating excessive daytime sleepiness in narcolepsy and obstructive sleep apnea (OSA). Decreased appetite was a common adverse event (AE) in clinical trials and these exploratory analyses sought to characterize the effects of solriamfetol on changes in body weight.
Changes in weight and AEs related to weight change were evaluated in two 12-week placebo-controlled, parallel group trials in narcolepsy and OSA, and in a 1-year open-label, long-term extension study.
Median weight at baseline was 82.3 kg for placebo and 79.3 kg for solriamfetol (combined doses) in narcolepsy, and 99.7 and 98.4 kg, respectively, in OSA. In narcolepsy, median (Q1,Q3) percent change in weight from baseline to week 12 was 3.1% (0.8,5.6) for placebo, 0.0% (-1.8,1.4) for 75mg, -0.4 (-1.9,0.6) for 150mg, and 0.0% (-2.1,1.2) for 300mg; in OSA was 0.5% (-0.7,2.0) for placebo, 0.0% (-1.5,1.2) for 37.5mg, -0.2% (-1.8,1.2), for 75mg, -1.1% (-3.0,0.3) for 150mg, and -1.9% (-4.9,0.0) for 300mg; and in the long-term trial (narcolepsy and OSA from parent baseline to week 40) was 0.6% (-1.1,3.2) for 75mg, -1.2% (-4.1,2.0) for 150mg, and -2.5% (-6.4,0.7) for 300mg. The percentage of participants with ≥5% weight decrease at week 12 in narcolepsy was 0% for placebo, 10.2% for 75mg, 6.0% for 150mg, and 7.0% for 300mg; in OSA was 6.9% for placebo, 4.1% for 37.5mg, 1.9% for 75mg, 8.4% for 150mg, and 24.5% for 300mg; and was 4.5%, 17.3%, and 32.4% for participants on maintenance doses of 75, 150, and 300 mg, respectively, in the long-term study. AEs of weight decreased were reported by 2.8% of participants in narcolepsy, 0.6% in OSA, and 0.8% in the long-term study.
Solriamfetol resulted in short-term and long-term decreases in body weight in participants with narcolepsy or OSA (range 0-2.5%), with few AEs of weight loss. Participants with OSA had higher weight at baseline and a greater percentage of participants with weight decrease ≥5%.
Jazz Pharmaceuticals
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