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Clinical Drug Investigation

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Open Access 22-02-2024 | Risperidone | Original Research Article

An Open-Label Study to Assess Monthly Risperidone Injections (180 mg) Following Switch from Daily Oral Risperidone (6 mg) in Stable Schizophrenic Patients

Authors: David P. Walling, Sunita N. Shinde, Janice M. Pogoda, Jahnavi Kharidia, Celine M. Laffont

Published in: Clinical Drug Investigation | Issue 4/2024

Abstract

Background and Objective

Long-acting injectable antipsychotics have shown benefits over oral medications with reduced hospitalization rates and improved health-related quality of life. RBP-7000 (PERSERIS^®) is a monthly risperidone formulation (90 or 120 mg) for the treatment of schizophrenia administered by subcutaneous abdominal injection. The objective of this study was to assess a higher dose of 180 mg RBP-7000 and an alternate injection site.

Methods

Following stabilization on 6 mg/day (3 mg twice daily) oral risperidone, clinically stable schizophrenic participants received 3 monthly doses of 180 mg RBP-7000 in the abdomen followed by a fourth monthly dose of 180 mg RBP-7000 in the upper arm (each dose administered as two 90-mg injections). The primary endpoint was the steady-state average plasma concentration (C_avg(ss)) of risperidone and total active moiety after oral and RBP-7000 administration. Secondary endpoints included measures of clinical efficacy (Positive and Negative Syndrome Scale, Clinical Global Impression Scale for Severity of Illness), safety, and local injection-site tolerability to assess the switch from oral risperidone and compare injection sites.

Results

In all, 23 participants received at least one dose of RBP-7000, 16 received all four doses, and 15 completed the study. Monthly doses of 180 mg RBP-7000 provided similar C_avg(ss) of total active moiety compared with 6 mg/day oral risperidone. The pharmacokinetics of RBP-7000 were similar after injection in the abdomen versus upper arm. Clinical efficacy measures remained stable throughout the study. All RBP-7000 injections were well tolerated with no unexpected safety findings.

Conclusions

The results support the use of 180 mg RBP-7000 in schizophrenic patients stable on 6 mg/day oral risperidone and a second injection site in the upper arm.

Trial Registration

ClinicalTrials.gov identifier: NCT03978832.

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Title: An Open-Label Study to Assess Monthly Risperidone Injections (180 mg) Following Switch from Daily Oral Risperidone (6 mg) in Stable Schizophrenic Patients
Authors: David P. Walling
Sunita N. Shinde
Janice M. Pogoda
Jahnavi Kharidia
Celine M. Laffont
Publication date: 22-02-2024
Publisher: Springer International Publishing
Keywords: Risperidone
Paliperidone
Schizophrenia
Antipsychotics
Antipsychotics
Published in: Clinical Drug Investigation / Issue 4/2024
Print ISSN: 1173-2563
Electronic ISSN: 1179-1918
DOI: https://doi.org/10.1007/s40261-024-01347-1

Keynote webinar | Spotlight on medication adherence

Springer Medicine

An Open-Label Study to Assess Monthly Risperidone Injections (180 mg) Following Switch from Daily Oral Risperidone (6 mg) in Stable Schizophrenic Patients

Abstract

Background and Objective

Methods

Results

Conclusions

Trial Registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background and Objective

Methods

Results

Conclusions

Trial Registration

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