A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active-controlled Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Bunionectomy
Phase of Trial: Phase III
Latest Information Update: 07 Mar 2018
At a glance
- Drugs Oliceridine (Primary) ; Morphine
- Indications Postoperative pain
- Focus Registrational; Therapeutic Use
- Acronyms APOLLO-1
- Sponsors Trevena
- 07 Mar 2018 According to a Trevena media release,The Company anticipates the PDUFA date for the NDA will be November 2, 2018 and Company expects commercial launch of OLINVO in the first quarter of 2019 following DEA scheduling.
- 02 Jan 2018 According to a Trevena media release, the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for OLINVO (oliceridine) Injection.The Company anticipates the PDUFA date for the NDA will be in the fourth quarter of 2018.
- 02 Nov 2017 According to a Trevena media release, company announced that it has recently submitted its New Drug Application (NDA) for OLINVOTM (oliceridine injection) to the U.S. Food and Drug Administration (FDA). Based on the data from APOLLO, ATHENA, other phase II and Phase III studies.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History