Trial reportClinical pharmacokinetics2014
Population pharmacokinetics and prediction of dopamine D2 receptor occupancy after multiple doses of RBP-7000, a new sustained-release formulation of risperidone, in schizophrenia patients on stable oral risperidone treatment.
Trial report in Clinical pharmacokinetics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.
- New Antipsychotic Medications in the Last Decade.Current psychiatry reports · 2021Pooled it
- An Open-Label Study to Assess Monthly Risperidone Injections (180 mg) Following Switch from Daily Oral Risperidone (6 mg) in Stable Schizophrenic Patients.Clinical drug investigation · 2024Trial
- Exposure-response analysis after subcutaneous administration of RBP-7000, a once-a-month long-acting Atrigel formulation of risperidone.British journal of clinical pharmacology · 2017Trial
- Population Pharmacokinetic-Based Strategies for Switching Patients with Schizophrenia Between Long-Acting Injectable Formulations of Risperidone: R064766 or RBP-7000 to TV-46000.Neurology and therapy · 2025Article
- Prescribing LAIs: from completing the first injection to going steady.CNS spectrums · 2025Review
- Phase-Inversion In Situ Systems: Problems and Prospects of Biomedical Application.Pharmaceutics · 2025Review
- Population Pharmacokinetics of Risperidone and Paliperidone in Schizophrenia: A Systematic Review.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Population Pharmacokinetic Modeling and Simulation of TV-46000: A Long-Acting Injectable Formulation of Risperidone.Clinical pharmacology in drug development · 2022Article
- Pharmacokinetic Characteristics of Long-Acting Injectable Antipsychotics for Schizophrenia: An Overview.CNS drugs · 2021Review
- Review
- PerserisP & T : a peer-reviewed journal for formulary management · 2019Article
- Correlation of hair risperidone concentration and serum level among patients with schizophrenia.General psychiatry · 2019Article
- Once-Monthly Subcutaneously Administered Risperidone in the Treatment of Schizophrenia: Patient Considerations.Patient preference and adherence · 2019Review
- Population Pharmacokinetics of an Extended-Release Formulation of Exenatide Following Single- and Multiple-Dose Administration.The AAPS journal · 2017Article
Corrections and comments
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Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectivesRBP-7000 is a long-acting formulation of risperidone administered once monthly via subcutaneous (SC) injections for the treatment of schizophrenia. The objectives of the present study were to characterize the pharmacokinetics of RBP-7000 after multiple doses in schizophrenic patients on stable oral risperidone therapy and to evaluate the switch between oral risperidone and SC injections of RBP-7000.
methodsData were collected in a phase IIa, open-label, multiple-ascending-dose study where 45 patients clinically stabilized on oral risperidone (2, 3 or 4 mg/day) were switched to receive 60, 90 or 120 mg/month SC injections of RBP-7000, respectively. Patients were thereafter switched back to oral risperidone. An integrated population pharmacokinetic model describing simultaneously risperidone and 9-hydroxyrisperidone after risperidone oral intake and RBP-7000 administration was developed in NON-MEM using 5,232 quantifiable plasma concentrations. Predictions of dopamine D2 receptor occupancy were derived using a previously published model.
resultsA two-compartment model with first-order absorption was selected for oral risperidone, while a three-compartment model with first-order absorption and a transit compartment absorption model was selected for RBP-7000. Body mass index was identified as a significant covariate affecting the initial absorption of risperidone following RBP-7000 injection. Steady state was reached after the second or third RBP-7000 injection but plasma concentrations close to steady-state values were obtained right after the first injection when switching from oral risperidone therapy. Predicted dopamine D2 receptor occupancy after repeated doses of 90 and 120 mg showed less fluctuation than after oral risperidone with acceptable ranges for clinical efficacy and a potentially safer profile with respect to extrapyramidal side effects.
conclusionThis analysis provided additional insight into the pharmacokinetics of RBP-7000 and for the comparison with oral risperidone treatment. The established model was used to support the design of a planned phase III study.
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