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A Six-Week, Double-Blind, Placebo-Controlled, Randomized- Withdrawal, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Obstructive Sleep Apnea (OSA)

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A Six-Week, Double-Blind, Placebo-Controlled, Randomized- Withdrawal, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Obstructive Sleep Apnea (OSA)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Sep 2022

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At a glance

  • Drugs Solriamfetol (Primary)
  • Indications Sleep apnoea syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms TONES 4
  • Sponsors Jazz Pharmaceuticals plc

    • Most Recent Events

    • 07 Sep 2022 According to an Axsome Therapeutics media release, post-hoc analysis results from NCT02348606 and NCT02348619 were published in the Journal of Psychiatric Research.
    • 07 Sep 2022 Post-hoc analysis results from NCT02348606 and NCT02348619 published in an Axsome Therapeutics Media Release.
    • 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.

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