An Open-Label, Long-Term Safety and Tolerability Study of Depot Buprenorphine (RBP-6000) in Treatment-Seeking Subjects With Opioid Use Disorder

Trial Profile

An Open-Label, Long-Term Safety and Tolerability Study of Depot Buprenorphine (RBP-6000) in Treatment-Seeking Subjects With Opioid Use Disorder

Completed
Phase of Trial: Phase III

Latest Information Update: 02 Aug 2017

At a glance

  • Drugs Buprenorphine (Primary) ; Buprenorphine
  • Indications Opioid abuse
  • Focus Adverse reactions; Registrational
  • Sponsors Indivior
  • Most Recent Events

    • 06 Feb 2017 Status changed from active, no longer recruiting to completed.
    • 23 Aug 2016 Status changed from recruiting to active, no longer recruiting.
    • 16 Aug 2016 According to an Indivior media release, company is on track to complete the data analysis of this and other trial (see profile 253758) by Q1 2017. Based on satisfactory completion of the analysis and assuming the U.S. FDA review and approval within the assumed six month Priority Review timeline, a marketing authorization could be granted in Q4 2017 per previous guidance.
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