A pivotal bioequivalence trial of buprenorphine/naloxone in patients with opioid dependence.
Phase of Trial: Phase III
Latest Information Update: 16 Mar 2015
At a glance
- Drugs Buprenorphine/naloxone (Primary)
- Indications Opioid abuse
- Focus Pharmacokinetics; Registrational
- 16 Mar 2015 A sNDA submission is anticipated by the fourth quarter of 2015, according to a BioDelivery Sciences International media release.
- 07 Aug 2013 Based on outcomes of this trial, and one other trial, an NDA was submitted to the FDA for BUNAVAIL [buprenorphine/naloxone], according to a BioDelivery Sciences International media release issued on 1 August 2013.
- 22 Jan 2013 Tolerability results have been reported in a BioDelivery Sciences International media release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History