A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy, Safety, and Dose-Response Study of Lofexidine in the Treatment of Opioid Withdrawal (Days 1-7) Followed by Open-Label, Variable Dose Lofexidine Treatment (Days 8-14)

Trial Profile

A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy, Safety, and Dose-Response Study of Lofexidine in the Treatment of Opioid Withdrawal (Days 1-7) Followed by Open-Label, Variable Dose Lofexidine Treatment (Days 8-14)

Completed
Phase of Trial: Phase III

Latest Information Update: 21 Nov 2017

At a glance

  • Drugs Lofexidine (Primary)
  • Indications Opioid abuse
  • Focus Registrational; Therapeutic Use
  • Sponsors US WorldMeds
  • Most Recent Events

    • 21 Nov 2017 According to an US WorldMeds media release,based on the data from this and other trial (see profile 251529), the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review of the New Drug Application (NDA) for lofexidine to mitigate symptoms associated with opioid withdrawal and facilitate completion of opioid discontinuation treatment. The Prescription Drug User Fee Act (PDUFA) date for lofexidine occurs during the second quarter of 2018.
    • 03 Mar 2015 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov
    • 01 Dec 2014 Planned End Date changed from 1 Sep 2014 to 1 Jan 2014 as reported by ClinicalTrials.gov
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