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

Trial Profile

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

Completed
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
  • Most Recent Events

    • 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.
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