A randomized study of solriamfetol for excessive sleepiness in narcolepsy

Michael J. Thorpy, Colin Shapiro, Geert Mayer, Bruce C. Corser, Helene Emsellem, Giuseppe Plazzi, Dan Chen, Lawrence P. Carter, Hao Wang, Yuan Lu, Jed Black, Yves Dauvilliers

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

Objective: Solriamfetol (JZP-110) is a selective dopamine and norepinephrine reuptake inhibitor with wake-promoting effects. This phase 3 study (NCT02348593) evaluated the safety and efficacy of solriamfetol in narcolepsy. Methods: Patients with narcolepsy with mean sleep latency <25 minutes on the Maintenance of Wakefulness Test (MWT), Epworth Sleepiness Scale (ESS) score ≥10, and usual nightly sleep ≥6 hours were randomized to solriamfetol 75, 150, or 300 mg, or placebo for 12 weeks. Coprimary endpoints were change from baseline to week 12 in MWT and ESS. Improvement on the Patient Global Impression of Change (PGI-C) was the key secondary endpoint. Results: Safety and modified intention-to-treat populations included 236 and 231 patients, respectively. Solriamfetol 300 and 150 mg were positive on both coprimary endpoints. Least squares mean (standard error [SE]) changes from baseline were 12.3 (SE = 1.4) and 9.8 (SE = 1.3) minutes for solriamfetol 300 and 150 mg on the MWT, respectively, versus 2.1 (SE = 1.3) minutes for placebo, and −6.4 (SE = 0.7) for 300 mg and −5.4 (SE = 0.7) for 150 mg on the ESS versus −1.6 (SE = 0.7) for placebo (all p < 0.0001). At week 12, higher percentages of patients treated with solriamfetol 150 mg (78.2%) and 300 mg (84.7%) reported PGI-C improvement relative to placebo (39.7%; both p < 0.0001). Adverse events ≥5% across all solriamfetol doses included headache (21.5%), nausea (10.7%), decreased appetite (10.7%), nasopharyngitis (9.0%), dry mouth (7.3%), and anxiety (5.1%). Interpretation: Solriamfetol has the potential to be an important therapeutic option for the treatment of impaired wakefulness and excessive sleepiness in patients with narcolepsy. ANN NEUROL 2019;85:359–370.

Original languageEnglish (US)
Pages (from-to)359-370
Number of pages12
JournalAnnals of Neurology
Volume85
Issue number3
DOIs
StatePublished - Mar 1 2019
Externally publishedYes

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Narcolepsy
Wakefulness
Placebos
Maintenance
Sleep
Nasopharyngitis
Dopamine Uptake Inhibitors
Safety
Appetite
Least-Squares Analysis
Nausea
Headache
Mouth
Norepinephrine
Anxiety
Therapeutics
Population

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

Cite this

Thorpy, M. J., Shapiro, C., Mayer, G., Corser, B. C., Emsellem, H., Plazzi, G., ... Dauvilliers, Y. (2019). A randomized study of solriamfetol for excessive sleepiness in narcolepsy. Annals of Neurology, 85(3), 359-370. https://doi.org/10.1002/ana.25423

A randomized study of solriamfetol for excessive sleepiness in narcolepsy. / Thorpy, Michael J.; Shapiro, Colin; Mayer, Geert; Corser, Bruce C.; Emsellem, Helene; Plazzi, Giuseppe; Chen, Dan; Carter, Lawrence P.; Wang, Hao; Lu, Yuan; Black, Jed; Dauvilliers, Yves.

In: Annals of Neurology, Vol. 85, No. 3, 01.03.2019, p. 359-370.

Research output: Contribution to journalArticle

Thorpy, MJ, Shapiro, C, Mayer, G, Corser, BC, Emsellem, H, Plazzi, G, Chen, D, Carter, LP, Wang, H, Lu, Y, Black, J & Dauvilliers, Y 2019, 'A randomized study of solriamfetol for excessive sleepiness in narcolepsy', Annals of Neurology, vol. 85, no. 3, pp. 359-370. https://doi.org/10.1002/ana.25423
Thorpy MJ, Shapiro C, Mayer G, Corser BC, Emsellem H, Plazzi G et al. A randomized study of solriamfetol for excessive sleepiness in narcolepsy. Annals of Neurology. 2019 Mar 1;85(3):359-370. https://doi.org/10.1002/ana.25423
Thorpy, Michael J. ; Shapiro, Colin ; Mayer, Geert ; Corser, Bruce C. ; Emsellem, Helene ; Plazzi, Giuseppe ; Chen, Dan ; Carter, Lawrence P. ; Wang, Hao ; Lu, Yuan ; Black, Jed ; Dauvilliers, Yves. / A randomized study of solriamfetol for excessive sleepiness in narcolepsy. In: Annals of Neurology. 2019 ; Vol. 85, No. 3. pp. 359-370.
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abstract = "Objective: Solriamfetol (JZP-110) is a selective dopamine and norepinephrine reuptake inhibitor with wake-promoting effects. This phase 3 study (NCT02348593) evaluated the safety and efficacy of solriamfetol in narcolepsy. Methods: Patients with narcolepsy with mean sleep latency <25 minutes on the Maintenance of Wakefulness Test (MWT), Epworth Sleepiness Scale (ESS) score ≥10, and usual nightly sleep ≥6 hours were randomized to solriamfetol 75, 150, or 300 mg, or placebo for 12 weeks. Coprimary endpoints were change from baseline to week 12 in MWT and ESS. Improvement on the Patient Global Impression of Change (PGI-C) was the key secondary endpoint. Results: Safety and modified intention-to-treat populations included 236 and 231 patients, respectively. Solriamfetol 300 and 150 mg were positive on both coprimary endpoints. Least squares mean (standard error [SE]) changes from baseline were 12.3 (SE = 1.4) and 9.8 (SE = 1.3) minutes for solriamfetol 300 and 150 mg on the MWT, respectively, versus 2.1 (SE = 1.3) minutes for placebo, and −6.4 (SE = 0.7) for 300 mg and −5.4 (SE = 0.7) for 150 mg on the ESS versus −1.6 (SE = 0.7) for placebo (all p < 0.0001). At week 12, higher percentages of patients treated with solriamfetol 150 mg (78.2{\%}) and 300 mg (84.7{\%}) reported PGI-C improvement relative to placebo (39.7{\%}; both p < 0.0001). Adverse events ≥5{\%} across all solriamfetol doses included headache (21.5{\%}), nausea (10.7{\%}), decreased appetite (10.7{\%}), nasopharyngitis (9.0{\%}), dry mouth (7.3{\%}), and anxiety (5.1{\%}). Interpretation: Solriamfetol has the potential to be an important therapeutic option for the treatment of impaired wakefulness and excessive sleepiness in patients with narcolepsy. ANN NEUROL 2019;85:359–370.",
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