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A Long-Term, Safety and Maintenance of Efficacy Study of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate hydrochloride] in the Treatment of Excessive Sleepiness in Subjects with Narcolepsy or Obstructive Sleep Apnea

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Trial Profile

A Long-Term, Safety and Maintenance of Efficacy Study of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate hydrochloride] in the Treatment of Excessive Sleepiness in Subjects with Narcolepsy or Obstructive Sleep Apnea

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 02 Sep 2021

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At a glance

  • Drugs Solriamfetol (Primary)
  • Indications Narcolepsy; Sleep apnoea syndrome
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms TONES-5
  • Sponsors Jazz Pharmaceuticals plc

    • Most Recent Events

    • 31 Aug 2021 According to a Jazz pharmaceutical media release, the Health Canada has given approval and availability of Sunosi for the treatment of excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea in adult patients based on data from TONES 2,3 ,4 and 5 trials.Once daily sunosis is approved with doses of 75mg and 150 mg.
    • 20 May 2020 Results from 12 week phase 3 trial and its open label extension presented at the 116th International Conference of the American Thoracic Society
    • 01 May 2020 Results assessing Long-Term Effects of Solriamfetol on Functioning and Work Productivity in Participants With Excessive Daytime Sleepiness Associated With Narcolepsy, presented at the 72nd Annual Meeting of the American Academy of Neurology
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