A Long-Term Safety and Maintenance of Efficacy Study ofJZP-110 [(R)-2-amino-3 Phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or Obstructive Sleep Apnea

Trial Profile

A Long-Term Safety and Maintenance of Efficacy Study ofJZP-110 [(R)-2-amino-3 Phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or Obstructive Sleep Apnea

Completed
Phase of Trial: Phase III

Latest Information Update: 12 Jan 2018

At a glance

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

    • 08 Jan 2018 Status changed from active, no longer recruiting to completed.
    • 20 Dec 2017 According to a Jazz Pharmaceuticals media release, based on the results of this trial, comapny has submitted an New Drug Application (NDA) to the U.S. Food and Drug Administration, seeking for the marketing approval of solriamfetol (JZP-110) for the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea (OSA).
    • 24 May 2017 Status changed from recruiting to active, no longer recruiting, According to a Jazz Pharmaceuticals media release.
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