Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess Efficacy of Multiple Subcutaneous Injections of Depot Buprenorphine (RBP 6000) Over 24 Weeks in Treatment-Seeking Participants With Opioid Use Disorder
Phase of Trial: Phase III
Latest Information Update: 02 Aug 2017
At a glance
- Drugs Buprenorphine (Primary) ; Buprenorphine (Primary)
- Indications Opioid abuse
- Focus Registrational; Therapeutic Use
- Sponsors Indivior
- 31 Jul 2017 According to an Indivior media release, U.S. Food and Drug Administration (FDA) has accepted with a Priority Review designation the New Drug Application (NDA) for RBP-6000, an investigational once-monthly injectable buprenorphine in the ATRIGEL delivery system for the treatment of adults with moderate-to-severe opioid use disorder (OUD) as part of a complete treatment plan to include counseling and psychosocial support.
- 21 Jun 2017 Results from this trial published in an Indivior Media Release.
- 21 Jun 2017 According to an Indivior media release data from this trial were presented at the 79th Annual Scientific Meeting of the College on Problems of Drug Dependence (CPDD).
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History