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

Research output: Contribution to journal › Article › Academic › peer-review

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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.

Original language	English
Article number	e2858
Number of pages	10
Journal	Human Psychopharmacology
Volume	38
Issue number	1
Early online date	24 Nov 2022
DOIs	https://doi.org/10.1002/hup.2858
Publication status	Published - Jan 2023

Funding

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.

Funders	Funder number
Jazz Pharmaceuticals	SKL-N05
ZonMw : Dutch Organisation for Health Research and Development
Nederlandse Organisatie voor Wetenschappelijk Onderzoek

Keywords

clinical trials
CNS
efficacy
neurology
pharmacotherapy
Carbamates/adverse effects
Double-Blind Method
Humans
Male
Phenylalanine/therapeutic use
Cross-Over Studies
Adult
Female
Narcolepsy/drug therapy
Automobile Driving

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1002/hup.2858

pdfFinal published version, 605 KBLicence: CC BY-NC

Cite this

@article{6fb4a678e3984f79a98119747b01460d,

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.",

keywords = "clinical trials, CNS, efficacy, neurology, pharmacotherapy, Carbamates/adverse effects, Double-Blind Method, Humans, Male, Phenylalanine/therapeutic use, Cross-Over Studies, Adult, Female, Narcolepsy/drug therapy, Automobile Driving",

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",

note = "{\textcopyright} 2022 The Authors. Human Psychopharmacology: Clinical and Experimental published by John Wiley \& Sons Ltd.",

year = "2023",

month = jan,

doi = "10.1002/hup.2858",

language = "English",

volume = "38",

journal = "Human Psychopharmacology",

issn = "0885-6222",

publisher = "Wiley",

number = "1",

}

TY - JOUR

T1 - Effects of solriamfetol on on-the-road driving in participants with narcolepsy

T2 - A randomised crossover trial

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

PY - 2023/1

Y1 - 2023/1

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.

KW - clinical trials

KW - CNS

KW - efficacy

KW - neurology

KW - pharmacotherapy

KW - Carbamates/adverse effects

KW - Double-Blind Method

KW - Humans

KW - Male

KW - Phenylalanine/therapeutic use

KW - Cross-Over Studies

KW - Adult

KW - Female

KW - Narcolepsy/drug therapy

KW - Automobile Driving

UR - https://www.scopus.com/pages/publications/85143389514

U2 - 10.1002/hup.2858

DO - 10.1002/hup.2858

M3 - Article

C2 - 36420633

SN - 0885-6222

VL - 38

JO - Human Psychopharmacology

JF - Human Psychopharmacology

IS - 1

M1 - e2858

ER -

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

Abstract

Funding

Keywords

UN SDGs

Access to Document

Other files and links

Fingerprint

Sleep Medicine

Cite this

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

Abstract

Funding

Keywords

UN SDGs

Access to Document

Other files and links

Fingerprint

Research areas

Sleep Medicine

Cite this