Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J - LARVOL DELTA

Generic Long-Acting Injectable Product Availability and Approval Standards. (PubMed, Pharm Res) - "These findings provide a foundation for harmonizing generic LAI approval standards, which may improve resource allocation, promote generic competition, and enhance patient access to LAI therapies."

Journal

Doses, plasma levels, and response of SGA long-acting injectable in patients with severe schizophrenia (WFSBP 2026) - " One-year prospective study with patients (N=68) with severe schizophrenia treated with paliperidone three-month (PP3M) or aripiprazole one-month (ARIM)... Considering the non-linear dose-PL relationship of ARIM and PP3M in people with severe schizophrenia, PLs above the TRR are linked to better treatment outcomes without worse tolerability. The need in a notable number of cases for high doses to reach those effective PLs is highlighted."

Clinical • CNS Disorders • Psychiatry • Schizophrenia

Weight and Metabolic Changes in Patients with Schizophrenia Treated with Paliperidone Palmitate 6-month formulation Versus Paliperidone Palmitate 3-month formulation: A Post-hoc Analysis. (PubMed, Int J Neuropsychopharmacol) - "This post-hoc analysis demonstrated that PP6M was comparable to PP3M in terms of metabolic parameters; however, it may have a beneficial effect on weight gain, especially in young patients."

Journal • Retrospective data • CNS Disorders • Dyslipidemia • Obesity • Psychiatry • Schizophrenia

Psychosis, Catatonia and Tachypnoea Following Paliperidone Palmitate 3-Monthly Injection Error: Case Report. (PubMed, Case Rep Psychiatry) - "Paliperidone palmitate 3-monthly (PP3M) is a long-acting Injection (LAI) formulation of the anti-psychotic medication paliperidone, also known as 9-hydroxyrisperidone (9-OH-RIS)...We share the use of electroconvulsive therapy (ECT) and oral lorazepam in managing this patient's acute psychosis and catatonia presentation and provide a rationale for the timing of safe recommencement of paliperidone oral medication. The patient was safely discharged home. We highlight the need for LAI overdose guidelines as an important area for review and development of clinical guidelines as we see increasing use of paliperidone palmitate 1-monthly (PP1M), PP3M, and paliperidone palmitate 6-monthly injection (PP6M) in the community."

Journal • CNS Disorders • Psychiatry

Fragile self, mechanical world: mechanistic delusions and ego fragility in schizotypal-affective spectrum disorder-a CARE case report. (PubMed, Front Psychiatry) - "During a seven-day inpatient course, a multimodal thymic strategy-risperidone, lithium carbonate, and structured psychotherapy-produced attenuation of paranoid reactivity, improved family engagement, and the spontaneous resumption of guitar playing from day 3, as a functional correlate of behavioral stabilization. The patient was discharged with a referral for a three-monthly paliperidone palmitate long-acting injectable. The pharmacological response retrospectively supports the dimensional formulation and illustrates the heuristic value of psychopathological analysis grounded in ego structure, causal reasoning, and affective dysregulation as a complementary approach to categorical nosology in complex psychotic-affective presentations."

Journal • Bipolar Disorder • CNS Disorders • Dyslipidemia • Metabolic Disorders • Mood Disorders • Psychiatry • Schizophrenia

A Claims Data-Based Comparison of Treatment Continuation between Aripiprazole Once-monthly and Paliperidone Palmitate in Routine Practice. (PubMed, Clin Psychopharmacol Neurosci) - "Aripiprazole once-monthly (AOM) and paliperidone palmitate once-monthly (PP1M) are commonly used long-acting injectable APs (LAIs) in routine practice. In this nationwide real-world study, AOM was associated with a lower risk of treatment discontinuation than PP1M over 12 months. These findings suggest differences in treatment continuation between the two LAIs and warrant confirmation in studies using more robust designs and diverse clinical data."

Journal • CNS Disorders • Psychiatry • Schizophrenia

Tardive Dyskinesia Induced by Long-Acting Injectable Paliperidone Palmitate Once Every 3 Months in a Patient With Schizophrenia: A Case Report and Literature Review. (PubMed, Clin Case Rep) - "Clinicians should regularly assess the risk of TD. They should promptly discontinue the long-acting medication, switch to an antipsychotic with a low risk of TD, and initiate supportive care as soon as signs of TD appear."

Journal • CNS Disorders • Movement Disorders • Psychiatry • Schizophrenia

Relapse rate, clinical efficacy, and safety of the 3-month paliperidone palmitate in community-dwelling patients with schizophrenia (CINP 2026) - "This study suggests that PP3M is effective in reducing relapse rates, alleviating symptoms, and improving both quality of life and social functioning among individuals with schizophrenia living in the community."

Clinical • CNS Disorders • Psychiatry • Schizophrenia

Change-points in patient-reported side effects following initiation of long-acting injectable antipsychotics: a longitudinal LUNSERS analysis (CINP 2026) - " We analyzed longitudinal LUNSERS data from patients treated with paliperidone palmitate (Invega Sustenna) or aripiprazole LAI (Abilify Maintena). Patient-reported side effects following LAI antipsychotic initiation do not appear to improve in a simple linear manner. Instead, many side effects demonstrate a clinically meaningful change-point after an early adaptation phase, beyond which improvement begins or accelerates. Recognizing these temporal patterns may help clinicians refine monitoring strategies, provide realistic expectations to patients during LAI initiation, and support treatment continuation."

Adverse events • Clinical • CNS Disorders • Schizophrenia

Efficacy and safety of long-acting injectable paliperidone palmitate 1-month and 3-month formulations in the maintenance treatment of schizophrenia: a single-arm, open-label, interventional study in Rwandan healthcare settings. (PubMed, BMJ Open) - P4 | "Switching from oral antipsychotics to PP1M followed by PP3M resulted in significant improvements in symptom severity and psychosocial functioning over 66 weeks, with no new safety concerns in this real-world Rwandan setting."

Journal • CNS Disorders • Infectious Disease • Nephrology • Psychiatry • Schizophrenia

Patient views on paliperidone palmitate 3-monthly: a cross-sectional questionnaire in UK community mental health teams. (PubMed, Ther Adv Psychopharmacol) - "The majority of respondents (83.8%) preferred PP3M over PP1M, with convenience being cited as the main reason for preference (62.9%). When asked about preferred injection frequency, patients overwhelmingly selected the 3-monthly (62.5%) or 6-monthly option (35.9%). Patients generally reported high levels of satisfaction with PP3M and perceived the treatment to be helpful and well-tolerated, with most expressing a preference for PP3M compared with a 1-monthly injection."

Journal • CNS Disorders • Pain • Psychiatry • Schizophrenia

Longitudinal Trajectories and Change-Points in LUNSERS Side Effects After Initiation of Long-Acting Injectable Antipsychotics (APA 2026) - " This study analyzed patients treated with LAI antipsychotics, specifically paliperidone palmitate (Invega Sustenna) and aripiprazole (Abilify Maintena). Patient-reported side effects following LAI initiation with Invega Sustenna or Abilify Maintena may not decline linearly; instead, improvement may begin or accelerate after an early adaptation period with a clinically meaningful change-point. Identifying when and which side effects improve can refine monitoring strategies during LAI initiation and support clinical expectations regarding tolerability over time. Future work should incorporate advanced missing-data approaches and relevant covariates (e.g., LAI formulation, dose, concomitant medications) in mixed-effects frameworks."

Adverse events • CNS Disorders

Antipsychotic Treatment Pathways, Real-World Adherence, Healthcare Resource Utilization, and Healthcare Costs Among Patients With Schizophrenia Treated With Once-Monthly, Once-Every-Three-Months, and Once-Every-Six-Months Paliperidone Palmitate in the United States. (PubMed, Clin Ther) - "Patients with schizophrenia using PP3M or PP6M were numerically more adherent to treatment, incurred lower medical costs, and a lower proportion had a schizophrenia-related inpatient admission relative to patients using PP1M, suggesting LAIs with longer dosing intervals may improve clinical outcomes and decrease economic burden."

HEOR • Journal • Real-world evidence • Retrospective data • CNS Disorders • Psychiatry • Schizophrenia

Virtual Bioequivalence Assessment of Long-acting Injectable Suspensions Using PBPK Modeling: Part 1. Impact of particle Size on Formulation Variability. (PubMed, AAPS J) - "This study presents a workflow for virtual bioequivalence (VBE) assessment of 3-month paliperidone palmitate (PP) long-acting injectable (LAI) suspensions using a novel physiologically-based pharmacokinetic (PBPK) model...The power calculations demonstrated that BE assessments were very sensitive to formulation differences in drug particle radius and to the parametrization of the model. These findings emphasize the critical need for rigorous model validation to ensure reliable VBE assessments."

Journal

Virtual Bioequivalence Assessment of Long-Acting Injectable Suspensions Using PBPK Modeling: Part 2. Type I Error and Safe Space Analyses. (PubMed, AAPS J) - "We present an analysis of statistical type I error and safe space calculations in virtual bioequivalence (VBE) assessments using a previously published physiologically-based pharmacokinetic (PBPK) model for 3-month long-acting paliperidone palmitate (PP) injectable suspensions...Our case study shows the conditions that allow for a controlled type I error in a VBE assessment. Safe space is shown to depend on both formulation characteristics and the statistical power afforded by BE studies, offering valuable insights for formulation design considerations."

Journal

Treatment continuation and factors associated with discontinuation with 3-month paliperidone palmitate in patients with schizophrenia: a post hoc analysis of post-marketing surveillance data in Japan. (PubMed, Front Psychiatry) - "Patients stabilized on paliperidone palmitate 1-month formulation for ≥4 months were transitioned to PP3M. These findings highlight the potential of PP3M to reduce pharmacologic burden and support long-term management of schizophrenia. https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000047973, identifier UMIN000042033."

Journal • P4 data • Retrospective data • CNS Disorders • Psychiatry • Schizophrenia

A Bioequivalence Study of PP3M in Patients With Schizophrenia (clinicaltrials.gov) - P=N/A | N=260 | Recruiting | Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

New trial • CNS Disorders • Psychiatry • Schizophrenia

Case Series: Simultaneous Use of Long-Acting Injectable Antipsychotics and Vivitrol or Long-Acting Buprenorphine in Dual Diagnosis Patients with Bipolar Disorder and Substance Use Disorders. (PubMed, Psychopharmacol Bull) - "Medication combinations included paliperidone palmitate with Sublocade (n = 2) and aripiprazole lauroxil with Sublocade (n = 1). This combination approach may be particularly valuable for patients with poor medication adherence. Preliminary findings support the need for controlled research to establish optimal patient selection criteria, medication combinations, and predictors of treatment response."

Journal • Retrospective data • Addiction (Opioid and Alcohol) • Bipolar Disorder • CNS Disorders • Mood Disorders • Psychiatry

Clinical Practice Recommendations for Switching from Once-Monthly to Longer-Interval Paliperidone Palmitate Injectable in Schizophrenia Patients: A Modified Delphi Study in China. (PubMed, Neuropsychiatr Dis Treat) - "Switching from short-interval LAIs (such as paliperidone palmitate one-month formulation, PP1M) to longer-intervals LAIs (like paliperidone palmitate three-month and six-month formulations) offers additional benefits to disease outcome. Final consensus was reached on 33 statements across five domains: clinical necessity, target patient populations, switching strategy, long-term disease management, factors influencing treatment willingness. It presents the first expert consensus in China on longer-interval LAIs usage in schizophrenia, offering evidence-informed guidance for patient selection, switching strategies and long-term disease management to promote standardized clinical use."

Journal • CNS Disorders • Mental Retardation • Psychiatry • Schizophrenia

Impact of macrophages on the dissolution of LAI suspension prodrugs. (PubMed, Int J Pharm) - "In this study, we investigated the role of macrophages in the dissolution and metabolic conversion of two clinically approved LAI prodrugs aripiprazole lauroxil (Aristada®) and paliperidone palmitate (Invega Trinza®) and their qualitatively and quantitatively (Q1Q2) equivalent formulations...Together, these findings suggest that macrophages complement the particle-size-dependent dissolution process by further modulating the dissolution and metabolic handling of LAI suspension prodrugs. This work provides new mechanistic insight into macrophage-mediated drug disposition at the injection site and has important implications for the design and performance prediction of LAI formulations."

Journal

Healthcare resource savings from administering paliperidone palmitate once every 3 months instead of once every month for schizophrenia: a 12-month mirror-image analysis of real-world population-based data. (PubMed, Ther Adv Psychopharmacol) - "Inadequate adherence to antipsychotic medication remains a major driver of relapse, hospitalization, and chronic disease progression in schizophrenia. Transitioning from PP1M to PP3M for schizophrenia treatment can significantly reduce healthcare resource utilization and costs. Notably, hospitalization and emergency room visit costs were reduced by approximately half."

Journal • Real-world evidence • CNS Disorders • Psychiatry • Schizophrenia

A Multicentre, 4-Year Mirror-Image Study Comparing the Effectiveness of Long-Acting Injectable Antipsychotics in the Treatment of Bipolar Disorder: Results From the LAICO Study. (PubMed, Bipolar Disord) - "Study findings suggest that long-acting antipsychotics such as A1M, PP1M, and particularly PP3M are associated with high retention and lower hospitalisation rates after 2 years of treatment in patients with BD."

Clinical • Journal • Bipolar Disorder • CNS Disorders • Mood Disorders • Psychiatry

Prolonged Tardive Dyskinesia Induced by Long-Acting Paliperidone Palmitate in Schizophrenia: A Case Report. (PubMed, Am J Case Rep) - "Dose reduction to 350 mg was ineffective; the long-acting injection was stopped in June 2019, and aripiprazole 10 mg/day was started. Adjuncts (trihexyphenidyl, amantadine, and intermittent benzodiazepines) provided only limited benefit...Over 6 years without vesicular monoamine transporter 2 (VMAT-2) inhibitors, her dystonia lessened but persisted, and she was discharged on clozapine and fluvoxamine...Given therapeutic limits, variable prognosis, and the 3-month formulation's extended pharmacokinetics, clinicians should maintain high suspicion, minimize dopamine-receptor-blocking exposure, and individualize care, considering timely VMAT-2 inhibitors or clozapine, plus structured long-term motor monitoring and shared decision-making. This report highlights the presentation of tardive dyskinesia as a complication of antipsychotic medication and the approach to management of this iatrogenic syndrome."

Journal • CNS Disorders • Dystonia • Movement Disorders • Psychiatry • Schizophrenia

Comparison of Side Effects Between 3-Monthly and 1-Monthly Paliperidone Palmitate Formulations in Patients With Schizophrenia. (PubMed, Hum Psychopharmacol) - "In this within-patient cohort stabilized on PP1M, conversion to PP3M was not associated with an increase in overall UKU side-effect burden. Selecting the appropriate dose before switching and preferring monotherapy may enhance treatment comfort. These results may help guide clinicians in selecting long-acting injectable antipsychotics in practice."

Adverse events • Clinical • Journal • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Psychiatry • Schizophrenia

12-Month mirror study on the effectiveness and safety of six-month paliperidone palmitate in patients with schizophrenia: A Multicenter Andalusian Cohort (PAPSEM study). (PubMed, Psychiatry Res) - "PP6M is an effective and well-tolerated option for patients with schizophrenia in real-world clinical practice. It reduces hospitalizations, improves clinical outcomes, and may contribute to decreased substance use."

Journal • CNS Disorders • Psychiatry • Schizophrenia