A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Assess the Efficacy, Safety, and Tolerability of Multiple Subcutaneous Injections of Depot Buprenorphine (RBP-6000 [100 mg and 300 mg]) Over 24 Weeks in Treatment-Seeking Subjects With Opioid Use Disorder

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Assess the Efficacy, Safety, and Tolerability of Multiple Subcutaneous Injections of Depot Buprenorphine (RBP-6000 [100 mg and 300 mg]) Over 24 Weeks in Treatment-Seeking Subjects With Opioid Use Disorder

Completed
Phase of Trial: Phase III

Latest Information Update: 22 Feb 2018

At a glance

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

    • 30 Nov 2017 Results presented in an Indivior Media Release.
    • 30 Nov 2017 According to an FDA media release, the US FDA has approved buprenorphine (Sublocade) for the treatment of moderate-to-severe opioid use disorder (OUD) in adult patients who have initiated treatment with a transmucosal (absorbed through mucus membrane) buprenorphine-containing product.
    • 31 Oct 2017 According to an Indivior media release, the Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA) voted 18 to 1 to recommend approval of RBP-6000 for the treatment of opioid use disorder (OUD). The FDA will consider the Advisory Committees' non-binding recommendation in its review of the NDA. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2017.
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