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Bioequivalence of abuse-deterrent, extended-release, oral morphine (Egalet-001) 60mg compared to MS Contin in healthy subjects

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Trial Profile

Bioequivalence of abuse-deterrent, extended-release, oral morphine (Egalet-001) 60mg compared to MS Contin in healthy subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 11 Jul 2019

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At a glance

  • Drugs Morphine (Primary)
  • Indications Pain
  • Focus Pharmacokinetics; Registrational
  • Sponsors Zyla Life Sciences

    • Most Recent Events

    • 20 May 2017 Results of this and another phase I study presented at the 36th Annual Scientific Meeting of the American Pain Society.
    • 17 May 2017 Data from this and another phase I trial (CTP 700254738) published in the Journal of Opioid Management, according to an Egalet Corporation media release.
    • 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.

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