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

IF 2.9 3区医学 Q2 PHARMACOLOGY & PHARMACY

Clinical Drug Investigation Pub Date : 2024-04-01 Epub Date: 2024-02-22 DOI:10.1007/s40261-024-01347-1

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

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引用次数: 0

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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一项开放标签研究，评估稳定期精神分裂症患者从每日口服利培酮（6 毫克）改为每月注射利培酮（180 毫克）的效果。

背景和目的：与口服药物相比，长效注射用抗精神病药物具有降低住院率和改善健康相关生活质量的优势。RBP-7000（PERSERIS®）是一种利培酮制剂（90 或 120 毫克），用于治疗精神分裂症，每月一次，腹部皮下注射给药。本研究的目的是评估 180 毫克 RBP-7000 的高剂量和替代注射部位：临床稳定的精神分裂症患者在每天口服 6 毫克（3 毫克，每天两次）利培酮的情况稳定后，每月在腹部注射 3 次 180 毫克 RBP-7000，然后每月在上臂注射第 4 次 180 毫克 RBP-7000（每次注射 2 次，每次 90 毫克）。主要终点是口服和RBP-7000给药后利培酮和总活性分子的稳态平均血浆浓度（Cavg(ss)）。次要终点包括临床疗效（阳性和阴性综合征量表、疾病严重程度临床总体印象量表）、安全性和局部注射部位耐受性，以评估从口服利培酮的转换情况并比较注射部位：共有 23 名参与者至少接受了一剂 RBP-7000，16 人接受了全部四剂，15 人完成了研究。与每天6毫克的口服利培酮相比，每月180毫克的RBP-7000可提供相似的总活性分子Cavg（ss）。腹部注射与上臂注射后，RBP-7000 的药代动力学相似。临床疗效指标在整个研究期间保持稳定。所有RBP-7000注射剂的耐受性都很好，没有意外的安全性发现：研究结果支持在口服利培酮6毫克/天且病情稳定的精神分裂症患者中使用180毫克RBP-7000，第二个注射部位为上臂：试验注册：ClinicalTrials.gov identifier：NCT03978832。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical Drug Investigation 医学-药学

CiteScore

5.90

自引率

3.10%

发文量

108

审稿时长

6-12 weeks

期刊介绍： Clinical Drug Investigation provides rapid publication of original research covering all phases of clinical drug development and therapeutic use of drugs. The Journal includes: -Clinical trials, outcomes research, clinical pharmacoeconomic studies and pharmacoepidemiology studies with a strong link to optimum prescribing practice for a drug or group of drugs. -Clinical pharmacodynamic and clinical pharmacokinetic studies with a strong link to clinical practice. -Pharmacodynamic and pharmacokinetic studies in healthy volunteers in which significant implications for clinical prescribing are discussed. -Studies focusing on the application of drug delivery technology in healthcare. -Short communications and case study reports that meet the above criteria will also be considered. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Clinical Drug Investigation may be accompanied by plain language summaries to assist readers who have some knowledge, but non in-depth expertise in, the area to understand important medical advances.