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 Obstructive Sleep Apnea (OSA)
Phase of Trial: Phase III
Latest Information Update: 06 Aug 2019
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At a glance
- Drugs Solriamfetol (Primary)
- Indications Sleep apnoea syndrome
- Focus Registrational; Therapeutic Use
- Acronyms TONES 3
- Sponsors Jazz Pharmaceuticals Inc
- 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).
- 21 Dec 2018 According to a Jazz Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has extended the review period for its new drug application (NDA) for solriamfetol as a treatment to improve wakefulness and reduce excessive daytime sleepiness in adult patients with narcolepsy or obstructive sleep apnea (OSA). The updated Prescription Drug User Fee Act (PDUFA) goal date is now March 20, 2019.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History