Objective: This post hoc analysis of an open-label, single-arm, multicenter study was designed to assess the efficacy, safety, and tolerability of paliperidone extended release (ER) in Chinese patients with non-acute schizophrenia, after switching from olanzapine.
Methods: Patients with schizophrenia who were dissatisfied with prior olanzapine treatment switched to flexible paliperidone ER (3-12 mg/day) based on clinical judgment. Change from baseline to week 12 in Positive and Negative Syndrome Scale (PANSS) total scores (primary endpoint), PANSS subscale scores, response rate, Clinical Global Impression-Severity (CGI-S) score, personal and social performance (PSP) scores, patient satisfaction with treatment score, change in sleep quality, level of daytime sleepiness and safety were evaluated.
Results: Out of 118 enrolled patients, 95 (81%) completed the study. Mean duration of study was 76.9 (23.85) days. The primary endpoint, mean (SD) PANSS total score changed significantly from baseline to endpoint (-19.6 [18.71], P <.0001). Secondary endpoints including PANSS subscale score, PSP, patient satisfaction and daytime drowsiness also significantly improved (P <.001). Most commonly reported (≥1%) treatment-emergent adverse events were akathisia (n = 14 [12%]) and insomnia (n = 9 [8%]).
Conclusions: Switching to flexible-dosed paliperidone ER in patients dissatisfied with prior olanzapine treatment achieved good efficacy and tolerability consistently over 12 weeks.
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http://dx.doi.org/10.1097/MD.0000000000013688 | DOI Listing |
BMC Psychiatry
January 2025
Department of Psychiatry, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-Ku, Yokohama, Kanagawa, 236-0004, Japan.
Background: Paliperidone is a second-generation antipsychotic and the main active metabolite of risperidone, formulated to provide consistent therapeutic effects through an extended-release system, designed to provide consistent therapeutic effects through an extended-release formulation. While commonly used in clinical practice, switching from risperidone to paliperidone, particularly during valproate therapy, can pose challenges due to potential pharmacokinetic interactions that may increase the risk of extrapyramidal symptoms (EPS). Despite clinical observations suggesting these interactions, case reports documenting such adverse effects are scarce.
View Article and Find Full Text PDFEur J Pharm Biopharm
November 2024
School of Pharmacy, Queen's University Belfast, 97 Lisburn Road, Belfast BT9 7BL, UK. Electronic address:
Schizophrenia is a severe mental disorder that affects millions of people worldwide. Several atypical antipsychotic medications, including paliperidone (PPD), has been developed and proven effective in treating it. To date, four PPD extended-release products have been launched commercially, providing up to six months of therapeutic effect with a single administration.
View Article and Find Full Text PDFJAMA Netw Open
July 2024
University Hospitals Cleveland Medical Center, Case Western Reserve University School of Medicine, Cleveland, Ohio.
Importance: Long-acting injectable (LAI) antipsychotics have the potential to improve adherence and symptom control in patients with schizophrenia, promoting long-term recovery. Paliperidone palmitate (PP) once every 6 months is the first and currently only LAI antipsychotic with an extended dosing interval of 6 months.
Objective: To assess long-term outcomes of PP received once every 6 months in adults with schizophrenia.
Eur J Drug Metab Pharmacokinet
July 2024
Janssen Research & Development, LLC, Turnhoutseweg 30, 2340, Beerse, Belgium.
Background And Objective: Paliperidone palmitate 6-month (PP6M) intramuscular (IM) injection is the longest-acting treatment available for patients with schizophrenia. A population pharmacokinetic (popPK) modeling and simulation approach was deployed to inform dosing strategies for PP6M.
Methods: The extensive analysis database included 15,932 paliperidone samples from 700 patients receiving gluteal paliperidone palmitate 3-month (PP3M) or PP6M injections in the double-blind phase of a phase-3 noninferiority study (NCT03345342).
Eur J Drug Metab Pharmacokinet
July 2024
Janssen Research and Development, Turnhoutseweg 30, 2340, Beerse, Belgium.
Background And Objective: A model-informed drug development (MIDD) approach was implemented for paliperidone palmitate (PP) 6-month (PP6M) clinical development, using pharmacokinetics and pharmacokinetic/pharmacodynamic model-based simulations.
Methods: PP6M pharmacokinetics were simulated by extending the PP 3-month (PP3M) pharmacokinetic model to account for increased injection volume, and hence dose. Contribution of the MIDD approach to the design of the pivotal PP6M phase-3 study (PP6M/PP3M noninferiority study, NCT03345342) investigating schizophrenia relapse rates was twofold: (1) PP6M dose selection, and (2) hypothesis generation that lower trough concentrations (C) associated with PP6M, relative to PP3M, were not associated with lower efficacy, which was to be evaluated in the phase-3 study.
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