An Open Label Study To Assess The Safety And Tolerability Of BEMA Buprenorphine NX In Opioid Dependent Subjects (BNX-201)
Phase of Trial: Phase II
Latest Information Update: 07 Apr 2017
At a glance
- Drugs Buprenorphine/naloxone (Primary)
- Indications Opioid abuse
- Focus Adverse reactions; 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 a bioequivalence 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.
- 01 Jan 2013 Status changed from recruiting to completed as reported by ClinicalTrials.gov.