Trial Profile
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)
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 29 Sep 2021
Price :
$35
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At a glance
- Drugs Risperidone (Primary) ; Risperidone (Primary)
- Indications Schizophrenia
- Focus Registrational; Therapeutic Use
- Sponsors Indivior; Reckitt Benckiser
- 12 Sep 2021 Results of an analysis using PANSS-item level data from this trial assessing efficacy and safety published in the Journal of Clinical Psychiatry
- 17 Nov 2020 According to a HLS Therapeutics media release, based on this study, Health Canada has approved the use of PERSERIS (risperidone for extended-release injectable suspension), 90 mg and 120 mg subcutaneous injection, a novel long-acting injectable of risperidone, for the treatment of schizophrenia in adults.
- 27 Feb 2019 According to an Indivior media release, the FDA approval of PERSERIS was based on the data from this pivotal phase 3 study.