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An Open Label Study To Assess The Safety And Tolerability Of BEMA Buprenorphine NX In Opioid Dependent Subjects (BNX-201)

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Trial Profile

An Open Label Study To Assess The Safety And Tolerability Of BEMA Buprenorphine NX In Opioid Dependent Subjects (BNX-201)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 07 Apr 2017

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At a glance

  • Drugs Buprenorphine/naloxone (Primary)
  • Indications Opioid-related disorders
  • Focus Adverse reactions; Registrational
  • Most Recent Events

    • 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.
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