An Open-Label, Long-Term Safety and Tolerability Study of RBP-7000 in the Treatment of Subjects With Schizophrenia
Phase of Trial: Phase III
Latest Information Update: 28 Sep 2017
At a glance
- Drugs Risperidone (Primary) ; Risperidone (Primary)
- Indications Schizophrenia
- Focus Adverse reactions; Registrational
- Sponsors Indivior; Reckitt Benckiser
- 28 Sep 2017 According to an Indivior media release, based on the data from this and other trial (see profile 243591), the company has submitted a New Drug Application (NDA) to the U.S. FDA to seek marketing approval for RBP-7000 in the ATRIGEL delivery system for the treatment of schizophrenia.
- 12 Jan 2017 Status changed from active, no longer recruiting to completed.
- 09 Sep 2016 Planned End Date changed from 1 Jul 2018 to 1 Dec 2016.