Bioequivalence study of an abuse-deterrent, extended-release oral morphine product Egalet 001 for the treatment of moderate to severe chronic pain in subjects in a fasted state

Trial Profile

Bioequivalence study of an abuse-deterrent, extended-release oral morphine product Egalet 001 for the treatment of moderate to severe chronic pain in subjects in a fasted state

Completed
Phase of Trial: Phase II

Latest Information Update: 13 Oct 2016

At a glance

  • Drugs Morphine (Primary)
  • Indications Pain
  • Focus Pharmacokinetics; Therapeutic Use
  • Most Recent Events

    • 13 Oct 2016 According to an Egalet media release, an FDA Advisory Committee voted 18 to 1 for approval of ARYMO ER and the Committee recommended ARYMO ER should be labeled as an abuse-deterrent product by the intravenous, nasal and oral routes of abuse.
    • 25 Aug 2016 According to an Egalet media release, the data of from trial would be presented PAINWeek 2016.
    • 29 Feb 2016 According to an Egalet media release, the US FDA has accepted the NDA for ARYMO ER (morphine sulfate) extended-release tablets for the treatment of severe pain.
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