A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Naldemedine in the Treatment of Opioid-induced Constipation in Subjects With Non-malignant Chronic Pain Receiving Opioid Therapy

Trial Profile

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Naldemedine in the Treatment of Opioid-induced Constipation in Subjects With Non-malignant Chronic Pain Receiving Opioid Therapy

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Jun 2017

At a glance

  • Drugs Naldemedine (Primary)
  • Indications Constipation
  • Focus Registrational; Therapeutic Use
  • Acronyms COMPOSE I; COMPOSE-1
  • Sponsors Shionogi
  • Most Recent Events

    • 23 Mar 2017 According to a Shionogi media release, the company has announced that the U.S. Food and Drug Administration (FDA) approved Symproic (naldemedine) 0.2 mg tablets C-II as a once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.
    • 19 Oct 2016 Results from two identically designed phase III trials (COMPOSE I and COMPOSE II) presented at the 24th United European Gastroenterology Week
    • 06 Jun 2016 According to a Shionogi media release, the New Drug Application (NDA) submitted in the U.S. for naldemedine, a once-daily, oral 0.2 mg tablet, has been accepted for review and the target action date under the Prescription Drug User Fee Act (PDUFA) is March 23, 2017.
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