TY - JOUR
T1 - Measures of functional outcomes, work productivity, and quality of life from a randomized, phase 3 study of solriamfetol in participants with narcolepsy
AU - Emsellem, Helene A.
AU - Thorpy, Michael J.
AU - Lammers, Gert Jan
AU - Shapiro, Colin M.
AU - Mayer, Geert
AU - Plazzi, Giuseppe
AU - Chen, Dan
AU - Carter, Lawrence P.
AU - Villa, Kathleen F.
AU - Lee, Lawrence
AU - Menno, Diane
AU - Black, Jed
AU - Dauvilliers, Yves
N1 - Funding Information:
This study was supported by Jazz Pharmaceuticals. In 2014, Jazz Pharmaceuticals acquired a license to develop and commercialize solriamfetol from Aerial Biopharma. Jazz Pharmaceuticals has worldwide development, manufacturing, and commercialization rights to solriamfetol, excluding certain jurisdictions in Asia. SK Biopharmaceuticals, the discoverer of the compound (also known as SKL-N05), maintains rights in 12 Asian markets, including Korea, China and Japan.
Funding Information:
HA Emsellem has received consultancy fees, honoraria, and/or has been a speakers' bureau member for Jazz Pharmaceuticals and Vanda Pharmaceuticals; has received research funding from Jazz Pharmaceuticals, Vanda Pharmaceuticals, Eisai, Flamel, and Merck & Co, Inc.; and is a board member of the National Sleep Foundation. MJ Thorpy has received research/grant support and consultancy fees from Jazz Pharmaceuticals, Merck & Co, Inc., and Teva Pharmaceutical Industries Ltd, and has been a member of the speakers' bureau for Jazz Pharmaceuticals and Cephalon, Inc. (now Teva Pharmaceutical Industries, Ltd.). GJ Lammers has received consultancy fees and/or honoraria and has been a speakers' bureau member and/or an advisory board participant for UCB Pharma, Bioprojet, Theranexus, and Jazz Pharmaceuticals. CM Shapiro has received research funding from the National Institutes of Health and the Canadian Institutes of Health Research and has served on the speakers' bureau for Jazz Pharmaceuticals. G Mayer has received honoraria from the Paul Ehrlich Institute, Germany; has served on the speakers' bureau for UCB Pharma and Sanofi; and is a board member of the European Narcolepsy Network. G Plazzi has received research support from UCB Pharma and consulted for UCB Pharma, Jazz Pharmaceuticals, and Bioprojet. D Chen , LP Carter , KF Villa , and D Menno are employees of Jazz Pharmaceuticals who, in the course of their employment, have received stock options exercisable for, and other stock awards of, ordinary shares of Jazz Pharmaceuticals plc. L Lee is a former employee of Jazz Pharmaceuticals who, in the course of his employment, received stock options exercisable for, and other stock awards of, ordinary shares of Jazz Pharmaceuticals plc. J Black is a part-time employee of Jazz Pharmaceuticals and shareholder of Jazz Pharmaceuticals plc. Y Dauvilliers has received consultancy fees and/or honoraria and has been a speakers’ bureau member and/or an advisory board participant for UCB Pharma, Bioprojet, Theranexus, Idorsia, Takeda, Flamel, and Jazz Pharmaceuticals. The ICMJE Uniform Disclosure Form for Potential Conflicts of Interest associated with this article can be viewed by clicking on the following link: https://doi.org/10.1016/j.sleep.2019.11.1250
Publisher Copyright:
© 2019 Elsevier B.V.
PY - 2020/3
Y1 - 2020/3
N2 - Objective: Solriamfetol (formerly JZP-110), a dopamine/norepinephrine reuptake inhibitor, is approved in the US to improve wakefulness in adults with excessive daytime sleepiness associated with narcolepsy (75–150 mg/d) or obstructive sleep apnea (37.5–150 mg/d). In a randomized, double-blind, placebo-controlled trial in participants with narcolepsy, effects of solriamfetol on functional status, health-related quality of life (HRQoL), and work productivity were evaluated. Methods: Participants with narcolepsy (N = 239) were randomized to solriamfetol 75, 150, or 300 mg, or placebo for 12 weeks. Outcome measures included the Functional Outcomes of Sleep Questionnaire short version (FOSQ-10), 36-Item Short Form Health Survey version 2 (SF-36v2), and Work Productivity and Activity Impairment questionnaire for Specific Health Problem (WPAI:SHP). A mixed-effects model with repeated measures was used for comparisons vs placebo. Results: At week 12, solriamfetol increased FOSQ-10 total score, with greatest mean difference from placebo (95% CI) at 300 mg (1.45 [0.31, 2.59]). On SF-36v2, improvements vs placebo were observed in physical component summary scores (300 mg: 2.22 [0.04, 4.41]) and subscales of role physical, general health, and vitality. On WPAI:SHP, solriamfetol 150 mg reduced overall work impairment vs placebo (−15.5 [−29.52, −1.47]), and 150 and 300 mg reduced activity impairment vs placebo (−10.05 [−19.48, −0.62] and −13.49 [−23.19, −3.78], respectively). Most treatment-emergent adverse events (TEAEs) were mild or moderate in severity. Common TEAEs were headache, nausea, decreased appetite, nasopharyngitis, dry mouth, and anxiety. Conclusions: Solriamfetol improved measures of functional status, HRQoL, and work productivity, particularly at the 150- and 300-mg doses. Most TEAEs were mild to moderate. Trial registration: ClinicalTrials.gov identifier NCT02348593, EudraCT number 2014-005487-15.
AB - Objective: Solriamfetol (formerly JZP-110), a dopamine/norepinephrine reuptake inhibitor, is approved in the US to improve wakefulness in adults with excessive daytime sleepiness associated with narcolepsy (75–150 mg/d) or obstructive sleep apnea (37.5–150 mg/d). In a randomized, double-blind, placebo-controlled trial in participants with narcolepsy, effects of solriamfetol on functional status, health-related quality of life (HRQoL), and work productivity were evaluated. Methods: Participants with narcolepsy (N = 239) were randomized to solriamfetol 75, 150, or 300 mg, or placebo for 12 weeks. Outcome measures included the Functional Outcomes of Sleep Questionnaire short version (FOSQ-10), 36-Item Short Form Health Survey version 2 (SF-36v2), and Work Productivity and Activity Impairment questionnaire for Specific Health Problem (WPAI:SHP). A mixed-effects model with repeated measures was used for comparisons vs placebo. Results: At week 12, solriamfetol increased FOSQ-10 total score, with greatest mean difference from placebo (95% CI) at 300 mg (1.45 [0.31, 2.59]). On SF-36v2, improvements vs placebo were observed in physical component summary scores (300 mg: 2.22 [0.04, 4.41]) and subscales of role physical, general health, and vitality. On WPAI:SHP, solriamfetol 150 mg reduced overall work impairment vs placebo (−15.5 [−29.52, −1.47]), and 150 and 300 mg reduced activity impairment vs placebo (−10.05 [−19.48, −0.62] and −13.49 [−23.19, −3.78], respectively). Most treatment-emergent adverse events (TEAEs) were mild or moderate in severity. Common TEAEs were headache, nausea, decreased appetite, nasopharyngitis, dry mouth, and anxiety. Conclusions: Solriamfetol improved measures of functional status, HRQoL, and work productivity, particularly at the 150- and 300-mg doses. Most TEAEs were mild to moderate. Trial registration: ClinicalTrials.gov identifier NCT02348593, EudraCT number 2014-005487-15.
KW - Excessive daytime sleepiness
KW - JZP-110
KW - Narcolepsy
KW - Solriamfetol
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U2 - 10.1016/j.sleep.2019.11.1250
DO - 10.1016/j.sleep.2019.11.1250
M3 - Article
C2 - 31926465
AN - SCOPUS:85077458508
SN - 1389-9457
VL - 67
SP - 128
EP - 136
JO - Sleep Medicine
JF - Sleep Medicine
ER -