Open-label, three-period crossover study evaluating the bioequivalence of abuse-deterrent, extended-release, oral morphine (Egalet-001) 30mg compared to MS Contin in healthy subjects

Trial Profile

Open-label, three-period crossover study evaluating the bioequivalence of abuse-deterrent, extended-release, oral morphine (Egalet-001) 30mg compared to MS Contin in healthy subjects

Completed
Phase of Trial: Phase I

Latest Information Update: 17 May 2017

At a glance

  • Drugs Morphine (Primary)
  • Indications Pain
  • Focus Pharmacokinetics; Registrational
  • Sponsors Egalet
  • Most Recent Events

    • 17 May 2017 Data from this and another phase I trial (CTP 700254740) 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.
    • 14 May 2016 Results from this trial and other trial (CTP-254740) presented at the 35th Annual Scientific Meeting of the American Pain Society
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top