Effects of solriamfetol on on-the-road driving in participants with narcolepsy: A randomised crossover trial

Frederick Vinckenbosch; Gert Jan Lammers; Sebastiaan Overeem; Dan Chen; Grace Wang; Lawrence P Carter; Kefei Zhou; Johannes G Ramaekers; Annemiek Vermeeren

doi:10.1002/hup.2858

Effects of solriamfetol on on-the-road driving in participants with narcolepsy: A randomised crossover trial

Frederick Vinckenbosch (Corresponding author)
, Gert Jan Lammers
, Sebastiaan Overeem
, Dan Chen
, Grace Wang
, Lawrence P Carter
, Kefei Zhou
, Johannes G Ramaekers
, Annemiek Vermeeren

Signal Processing Systems

Onderzoeksoutput: Bijdrage aan tijdschrift › Tijdschriftartikel › Academic › peer review

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OBJECTIVE: To evaluate the impact of solriamfetol, a dopamine and norepinephrine reuptake inhibitor, on on-the-road driving performance in participants with narcolepsy.

METHODS: In this randomised, double-blind, placebo-controlled, crossover study, driving performance during a 1 h on-road driving test was assessed at 2 and 6 h post-dose following 7 days of treatment with solriamfetol (150 mg/day for 3 days, followed by 300 mg/day for 4 days) or placebo. The primary endpoint was standard deviation of lateral position (SDLP) at 2 h post-dose.

RESULTS: The study included 24 participants (54% male; mean age, 40 years); 22 had evaluable SDLP data. At 2 h post-dose, median SDLP was significantly lower (improved) with solriamfetol compared with placebo (19.08 vs. 20.46 cm [median difference, -1.9 cm], p = 0.002). Four participants on solriamfetol and 7 on placebo had incomplete driving tests. At 6 h post-dose, median SDLP was not statistically significantly different with solriamfetol compared with placebo (19.59 vs. 19.78 cm [median difference, -1.1 cm], p = 0.125). Three participants on solriamfetol and 10 on placebo had incomplete driving tests. Common adverse events (≥5%) included headache, decreased appetite, and somnolence.

CONCLUSIONS: Solriamfetol 300 mg/day improved on-the-road driving performance, at 2 h post-administration in participants with narcolepsy.

Originele taal-2	Engels
Artikelnummer	e2858
Aantal pagina's	10
Tijdschrift	Human Psychopharmacology
Volume	38
Nummer van het tijdschrift	1
Vroegere onlinedatum	24 nov. 2022
DOI's	https://doi.org/10.1002/hup.2858
Status	Gepubliceerd - jan. 2023

Bibliografische nota

Financiering

Under the direction of the authors, Sherri D. Jones, PharmD, and Christopher Jaworski of Peloton Advantage, LLC, an OPEN Health company, provided medical writing and editorial support for this article, which was funded by Jazz Pharmaceuticals. This study was supported by Jazz Pharmaceuticals (Dublin, Ireland). At the time the study was conducted, Jazz Pharmaceuticals had worldwide development, manufacturing, and commercialisation rights to solriamfetol, excluding certain jurisdictions in Asia. Jazz Pharmaceuticals completed the divestiture of Sunosi® (solriamfetol) to Axsome Therapeutics, Inc. in the US on May 9, 2022 and ex-US on November 14, 2022. SK Biopharmaceuticals, the discoverer of the compound (also known as SKL-N05), maintains rights in 12 Asian markets, including Korea, China, and Japan. Frederick Vinckenbosch is an employee of Maastricht University. Maastricht University received financial support to conduct the present study. Gert Jan 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. Sebastiaan Overeem has received an unrestricted grant from UCB Pharma for research unrelated to this work and served on advisory boards for UCB Pharma and Jazz Pharmaceuticals, all paid to institution. Dan Chen, Grace Wang, Lawrence P. Carter, and Kefei Zhou are former employees of Jazz Pharmaceuticals who, in the course of their employment, received stock options exercisable for, and other stock awards of, ordinary shares of Jazz Pharmaceuticals plc. Johannes G. Ramaekers has received grants from pharmaceutical industries as well as national (NWO, ZonMw) and international (EU Commission) funding bodies that are unrelated to this work. Annemiek Vermeeren is an employee of Maastricht University. Maastricht University received financial support to conduct the present study. Under the direction of the authors, Sherri D. Jones, PharmD, and Christopher Jaworski of Peloton Advantage, LLC, an OPEN Health company, provided medical writing and editorial support for this article, which was funded by Jazz Pharmaceuticals. This study was supported by Jazz Pharmaceuticals (Dublin, Ireland). At the time the study was conducted, Jazz Pharmaceuticals had worldwide development, manufacturing, and commercialisation rights to solriamfetol, excluding certain jurisdictions in Asia. Jazz Pharmaceuticals completed the divestiture of Sunosi® (solriamfetol) to Axsome Therapeutics, Inc. in the US on May 9, 2022 and ex‐US on November 14, 2022. SK Biopharmaceuticals, the discoverer of the compound (also known as SKL‐N05), maintains rights in 12 Asian markets, including Korea, China, and Japan.

Financiers	Financiernummer
Jazz Pharmaceuticals	SKL-N05
ZonMw : Dutch Organisation for Health Research and Development
Nederlandse Organisatie voor Wetenschappelijk Onderzoek

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title = "Effects of solriamfetol on on-the-road driving in participants with narcolepsy: A randomised crossover trial",

abstract = "OBJECTIVE: To evaluate the impact of solriamfetol, a dopamine and norepinephrine reuptake inhibitor, on on-the-road driving performance in participants with narcolepsy.METHODS: In this randomised, double-blind, placebo-controlled, crossover study, driving performance during a 1 h on-road driving test was assessed at 2 and 6 h post-dose following 7 days of treatment with solriamfetol (150 mg/day for 3 days, followed by 300 mg/day for 4 days) or placebo. The primary endpoint was standard deviation of lateral position (SDLP) at 2 h post-dose.RESULTS: The study included 24 participants (54\% male; mean age, 40 years); 22 had evaluable SDLP data. At 2 h post-dose, median SDLP was significantly lower (improved) with solriamfetol compared with placebo (19.08 vs. 20.46 cm [median difference, -1.9 cm], p = 0.002). Four participants on solriamfetol and 7 on placebo had incomplete driving tests. At 6 h post-dose, median SDLP was not statistically significantly different with solriamfetol compared with placebo (19.59 vs. 19.78 cm [median difference, -1.1 cm], p = 0.125). Three participants on solriamfetol and 10 on placebo had incomplete driving tests. Common adverse events (≥5\%) included headache, decreased appetite, and somnolence.CONCLUSIONS: Solriamfetol 300 mg/day improved on-the-road driving performance, at 2 h post-administration in participants with narcolepsy.",

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author = "Frederick Vinckenbosch and Lammers, \{Gert Jan\} and Sebastiaan Overeem and Dan Chen and Grace Wang and Carter, \{Lawrence P\} and Kefei Zhou and Ramaekers, \{Johannes G\} and Annemiek Vermeeren",

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AU - Vinckenbosch, Frederick

AU - Lammers, Gert Jan

AU - Overeem, Sebastiaan

AU - Chen, Dan

AU - Wang, Grace

AU - Carter, Lawrence P

AU - Zhou, Kefei

AU - Ramaekers, Johannes G

AU - Vermeeren, Annemiek

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N2 - OBJECTIVE: To evaluate the impact of solriamfetol, a dopamine and norepinephrine reuptake inhibitor, on on-the-road driving performance in participants with narcolepsy.METHODS: In this randomised, double-blind, placebo-controlled, crossover study, driving performance during a 1 h on-road driving test was assessed at 2 and 6 h post-dose following 7 days of treatment with solriamfetol (150 mg/day for 3 days, followed by 300 mg/day for 4 days) or placebo. The primary endpoint was standard deviation of lateral position (SDLP) at 2 h post-dose.RESULTS: The study included 24 participants (54% male; mean age, 40 years); 22 had evaluable SDLP data. At 2 h post-dose, median SDLP was significantly lower (improved) with solriamfetol compared with placebo (19.08 vs. 20.46 cm [median difference, -1.9 cm], p = 0.002). Four participants on solriamfetol and 7 on placebo had incomplete driving tests. At 6 h post-dose, median SDLP was not statistically significantly different with solriamfetol compared with placebo (19.59 vs. 19.78 cm [median difference, -1.1 cm], p = 0.125). Three participants on solriamfetol and 10 on placebo had incomplete driving tests. Common adverse events (≥5%) included headache, decreased appetite, and somnolence.CONCLUSIONS: Solriamfetol 300 mg/day improved on-the-road driving performance, at 2 h post-administration in participants with narcolepsy.

AB - OBJECTIVE: To evaluate the impact of solriamfetol, a dopamine and norepinephrine reuptake inhibitor, on on-the-road driving performance in participants with narcolepsy.METHODS: In this randomised, double-blind, placebo-controlled, crossover study, driving performance during a 1 h on-road driving test was assessed at 2 and 6 h post-dose following 7 days of treatment with solriamfetol (150 mg/day for 3 days, followed by 300 mg/day for 4 days) or placebo. The primary endpoint was standard deviation of lateral position (SDLP) at 2 h post-dose.RESULTS: The study included 24 participants (54% male; mean age, 40 years); 22 had evaluable SDLP data. At 2 h post-dose, median SDLP was significantly lower (improved) with solriamfetol compared with placebo (19.08 vs. 20.46 cm [median difference, -1.9 cm], p = 0.002). Four participants on solriamfetol and 7 on placebo had incomplete driving tests. At 6 h post-dose, median SDLP was not statistically significantly different with solriamfetol compared with placebo (19.59 vs. 19.78 cm [median difference, -1.1 cm], p = 0.125). Three participants on solriamfetol and 10 on placebo had incomplete driving tests. Common adverse events (≥5%) included headache, decreased appetite, and somnolence.CONCLUSIONS: Solriamfetol 300 mg/day improved on-the-road driving performance, at 2 h post-administration in participants with narcolepsy.

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KW - Carbamates/adverse effects

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KW - Male

KW - Phenylalanine/therapeutic use

KW - Cross-Over Studies

KW - Adult

KW - Female

KW - Narcolepsy/drug therapy

KW - Automobile Driving

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DO - 10.1002/hup.2858

M3 - Article

C2 - 36420633

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JO - Human Psychopharmacology

JF - Human Psychopharmacology

IS - 1

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Effects of solriamfetol on on-the-road driving in participants with narcolepsy: A randomised crossover trial

Samenvatting

Bibliografische nota

Financiering

Duurzame ontwikkelingsdoelstellingen van de VN

Toegang tot document

Andere bestanden en links

Vingerafdruk

Impact

Sleep Medicine

Citeer dit