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
Phase of Trial: Phase I
Latest Information Update: 17 May 2017
At a glance
- Drugs Morphine (Primary)
- Indications Pain
- Focus Pharmacokinetics; Registrational
- Sponsors Egalet
- 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