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: 03 Oct 2017
At a glance
- Drugs Buprenorphine (Primary) ; Buprenorphine (Primary)
- Indications Opioid abuse
- Focus Registrational; Therapeutic Use
- Sponsors Indivior
- 03 Oct 2017 According to an Indivior media release, the U.S. Food and Drug Administration (FDA) published notice via the Federal Register, that a joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will review Indiviors New Drug Application (NDA) for RBP-6000 on October 31, 2017.
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History