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
Phase of Trial: Phase II
Latest Information Update: 13 Oct 2016
At a glance
- Drugs Morphine (Primary)
- Indications Pain
- Focus Pharmacokinetics; Therapeutic Use
- 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.