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)
Phase of Trial: Phase III
Latest Information Update: 02 Mar 2018
At a glance
- Drugs Solriamfetol (Primary)
- Indications Sleep apnoea syndrome
- Focus Registrational; Therapeutic Use
- Acronyms TONES 4
- Sponsors Jazz Pharmaceuticals plc
- 02 Mar 2018 According to a Jazz Pharmaceuticals media release, the US FDA has accepted the New Drug Application (NDA) for solriamfetol (JZP-110) for the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea (OSA). The Prescription Drug User Fee Act (PDUFA) goal date for an FDA decision is December 20, 2018.
- 20 Dec 2017 According to a Jazz Pharmaceuticals media release, based on the results of this trial, company 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).
- 19 Oct 2017 Status changed from active, no longer recruiting to completed.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History