A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of RBP-7000 as a Treatment in Subjects With Acute Schizophrenia Over 8 Weeks (2 Subcutaneous Doses)
Phase of Trial: Phase III
Latest Information Update: 12 Dec 2017
At a glance
- Drugs Risperidone (Primary) ; Risperidone (Primary)
- Indications Schizophrenia
- Focus Registrational; Therapeutic Use
- Sponsors Indivior; Reckitt Benckiser
- 12 Dec 2017 According to an Indivior media release,The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for RBP-7000, an investigational, once-monthly injectable risperidone in the ATRIGEL delivery system for the treatment of schizophrenia.The FDA has set a PDUFA (Prescription Drug User Fee Act) target action date of July 28, 2018.
- 28 Sep 2017 According to an Indivior media release, based on the data from this and other trial (see profile 247838), 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.
- 30 Jan 2017 Results of exposure-response analysis for RBP-7000, published in the British Journal of Clinical Pharmacology.