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A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, 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 Narcolepsy

Trial Profile

A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, 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 Narcolepsy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Aug 2019

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At a glance

  • Drugs Solriamfetol (Primary)
  • Indications Narcolepsy
  • Focus Registrational; Therapeutic Use
  • Acronyms TONES-002; TONES-2
  • Sponsors Jazz Pharmaceuticals Inc
  • Most Recent Events

    • 06 Aug 2019 According to a Jazz Pharmaceuticals media release, EU approval is anticipated for as early as year-end.
    • 20 Mar 2019 According to a Jazz Pharmaceuticals media release, based on the data from the TONES Phase 3 clinical program, which include four studies, the U.S. Food and Drug Administration (FDA) approved Sunosi (solriamfetol) to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA).
    • 29 Jan 2019 Results determining whether two intravenous (IV) TXA regimens (a three-hour two-dose (short-TXA) and 11-hour four-dose (long-TXA)) were more effective than placebo published in the Annals of Neurology.
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