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: 16 May 2018

At a glance

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

    • 16 May 2018 According to the Food and Drug Administration media release, the U.S. Food and Drug Administration today approved Lucemyra (lofexidine hydrochloride) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults.
    • 27 Mar 2018 According to an US WorldMeds media release, the US Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee voted 11 to 1 to recommend approval of lofexidine for mitigating opioid withdrawal symptoms. If approved, lofexidine will be marketed under the brand name LUCEMYRA.
    • 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.
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