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Psych Congress  

Quality of Life, Functional Evaluation, and Work Productivity in Patients With Narcolepsy: Results From a Phase 3 Study of Solriamfetol (JZP-110)


Michael Thorpy, MB, ChB – Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY; Yves Dauvilliers, MD, PhD – Gui-de-Chauliac Hospital, CHU Montpellier, INSERM U1061, Montpellier, France; Gert Jan Lammers, MD, PhD – Department of Neurology, Leiden University Medical Center, Leiden, The Netherlands;  Sleep-Wake Center Stichting Epilepsie Instellingen Nederland (SEIN), Heemstede, The Netherlands; Colin Shapiro, PhD – Dept Psychiatry, University of Toronto, Toronto, ON, Canada; Geert Mayer, MD – Hephata Klinik, Schwalmstadt, Germany; Philipps University, Marburg, Germany; Giuseppe Plazzi, MD – Department of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy; Dan Chen, MD – Jazz Pharmaceuticals, Palo Alto, CA ; Lawrence Carter, PhD – Jazz Pharmaceuticals, Palo Alto, CA; University of Arkansas for Medical Sciences, Little Rock, AR; Robert Ryan, MS – Jazz Pharmaceuticals, Philadelphia, PA; Jed Black, MD – Jazz Pharmaceuticals, Palo Alto, CA; Stanford Center for Sleep Sciences and Medicine, Palo Alto, CA; Helene Emsellem, MD – The Center for Sleep & Wake Disorders, Chevy Chase, MD; George Washington University Medical Center, Washington, DC

Jazz Pharmaceuticals

INTRODUCTION: Solriamfetol, a selective dopamine/norepinephrine reuptake inhibitor, significantly decreased excessive sleepiness in a randomized, double-blind, placebo-controlled study of adults with narcolepsy. Health-related quality of life (HRQoL) results (secondary endpoints) are reported here.

METHODS: Participants with narcolepsy (n=239) were randomized to solriamfetol (75, 150, or 300 mg) or placebo for 12 weeks. Assessments included Functional Outcomes of Sleep Questionnaire 10-item (FOSQ-10), Work Productivity and Activity Impairment questionnaire for Specific Health Problems (WPAI:SHP), and 36-Item Short Form Health Survey version 2 (SF-36v2). Least squares mean (standard error) changes from baseline to week 12 were calculated for each measure. Reported P values are nominal. Safety and tolerability were also assessed.

RESULTS: Solriamfetol 300 mg improved the FOSQ-10 (300 mg, 3.01 [0.42]; placebo, 1.56 [0.40]; P<0.05). Solriamfetol 150 mg reduced percent overall work impairment on the WPAI:SHP (150 mg, –19.77 [5.04]; placebo, –4.28 [5.00]; P<0.05) and reduced percent activity impairment at 300 and 150 mg (300 mg, –21.27 [3.55]; 150 mg, –17.84 [3.35]; placebo, –7.79 [3.42]; P<0.05). Improvements in SF-36v2 domains were seen for role physical (300 mg; P<0.05) and vitality (all doses; P<0.05). The most common treatment-emergent adverse events were headache, nausea, decreased appetite, nasopharyngitis, dry mouth, and anxiety.'

CONCLUSIONS: Solriamfetol improved functioning and HRQoL at 300 mg, specifically on the SF-36v2 vitality and role physical domains. Improvement in impairment at work (150 mg) and activity impairment outside of work (300 and 150 mg) was also demonstrated. Safety and tolerability were consistent with previous solriamfetol studies.

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