Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J - LARVOL DELTA

Population Pharmacokinetics and Dosing Simulations for Paliperidone Palmitate 351 mg as Alternative Maintenance Doses in Patients With Schizophrenia or Schizoaffective Disorder. (PubMed, J Clin Psychiatry) - P1 | "A 351 mg dose of PP1M (LY03010 [brand name Erzofri]) became available in the US in April 2025 and is approved as a single initiation injection followed by recommended monthly maintenance doses up to 234 mg. Currently, there are no clinical data to support the alternative dosing regimens. Trial Registration: ClinicalTrials.gov identifiers: NCT04572685 and NCT04922593."

Journal • PK/PD data • CNS Disorders • Psychiatry • Schizophrenia

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

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

The efficacy and safety of paliperidone palmitate injection(II) as a replacement for oral medication in the treatment of schizophrenia (ChiCTR) - P4 | N=120 | Not yet recruiting | Sponsor: Nanjing Brain Hospital; Nanjing Brain Hospital

New P4 trial • 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

Navigating the Transition from Oral Antipsychotics to Paliperidone Palmitate: A Review of Pharmacokinetics Evidence and Clinical Best Practice (APA 2026) - "Manufacturer guidelines for paliperidone palmitate monthly indicate oral overlap is unnecessary when standard loading regimens are followed... Critical gaps exist between pharmacokinetic theory, practice patterns, and clinical outcomes. While population models support manufacturer recommendations, case evidence suggests subset vulnerability during transition. Absence of standardized protocols and conflicting data prevent definitive conclusions."

Clinical • PK/PD data • Review • CNS Disorders • 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

HOSPITAL BUDGET IMPACT MODEL OF TV-46000, A LONG-ACTING SUBCUTANEOUS FORMULATION OF RISPERIDONE, VERSUS ONCE-MONTHLY PALIPERIDONE PALMITATE IN ADULTS WITH SCHIZOPHRENIA IN THE UNITED STATES (ISPOR 2026) - "These findings demonstrate the potential economic benefits of TV-46000 versus PP1m for adults with schizophrenia from a US hospital perspective."

Clinical • HEOR • CNS Disorders • Psychiatry • Schizophrenia

Cost-effectiveness analysis of treatment strategies initiating with second-generation antipsychotic long-acting injectables in patients with schizophrenia in the United States. (PubMed, J Manag Care Spec Pharm) - "To compare the cost-effectiveness of treatment strategies initiating with 4 SGA LAIs, aripiprazole monohydrate, aripiprazole lauroxil, olanzapine pamoate, and risperidone, with the strategy initiating with monthly paliperidone palmitate in patients with schizophrenia from the US health care sector perspective...Patients transitioned to additional lines of therapy (another SGA LAI and then clozapine) after relapse or intolerance to side effects...Sensitivity analysis confirmed the robustness of these findings, with LAI drug costs and relapse probabilities being the most influential parameters. Over a 5-year horizon, the treatment strategy initiating with paliperidone emerged as a favorable LAI option, providing the highest QALY gains at comparable or lower costs than the other LAI-initiating strategies."

Clinical • HEOR • Journal • CNS Disorders • Diabetes • Metabolic Disorders • Psychiatry • Schizophrenia

Use of Long-acting Injectable Antipsychotic Drugs in the Elderly: A Retrospective Study. (PubMed, Clin Psychopharmacol Neurosci) - "The most frequently used oral antipsychotic in combination with LAIA was olanzapine, used in 64 (34.2%) cases...The utilisation of LAIAs in elderly patients appears to be both tolerable and safe. It can be considered for elderly patients suffering from chronic mental illness who are non-compliant with treatment."

Journal • Retrospective data • Bipolar Disorder • CNS Disorders • Geriatric Disorders • Mood Disorders • Psychiatry • Schizophrenia

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

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

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

Antipsychotic prescribing patterns in a state psychiatric hospital with predominantly forensic admissions. (PubMed, Front Psychiatry) - "About one-third of patients were prescribed olanzapine (N = 76; 35.8%), and about a quarter of patients were prescribed clozapine (N = 51; 24.1%) and/or paliperidone (including Invega Sustenna) (N = 49; 23.1%). Larger, multicenter studies are needed to determine how antipsychotic prescribing patterns vary between U.S. state hospitals. Testing the development and implementation of antipsychotic stewardship programs in state hospital settings is recommended to establish best practices for monitoring antipsychotic use patterns and associated health outcomes."

Journal • CNS Disorders • Psychiatry

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

Study on the Interaction of Functionalized Doped Graphene Quantum Dots by S-Allylcysteine and Serum Albumin Using Fluorescence Spectroscopy and Molecular Docking Techniques. (PubMed, Langmuir) - "Steady-state and time-resolved fluorescence measurements revealed distinct quenching mechanisms: SAC exhibited static quenching through ground-state complex formation (KSV = 2 × 10-4 ppm1 at 298 K) with preserved HSA conformation (Δα-helix 0), with SAC showing temperature-enhanced affinity (Ka increased from 1.2474 to 1.9902 ppm-1, 298-318 K). These findings provide critical insights for designing HSA-based delivery systems, highlighting SAC's structural preservation advantages and DGQD/SAC's tunable interfacial interactions."

Journal

Inpatient prescribing trends and differences in drug acquisition costs of long-acting injectable subcutaneous risperidone versus paliperidone palmitate: A single-center medication use evaluation. (PubMed, Ment Health Clin) - "Literature comparing differences in efficacy of inpatient initiation of long-acting paliperidone palmitate once monthly (PP1M) and subcutaneous risperidone long acting-injectable (SC-RLAI) is currently limited and inconclusive. Inpatient institutions may have an opportunity to decrease drug costs by switching from PP1M to SC-RLAI1M as a formulary-preferred medication when appropriate. However, administrators should consider institution-specific costs as well as product availability for patients after discharge."

Journal

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

Clinical remission, functional recovery, and employment in early-phase schizophrenia treated with paliperidone palmitate: An 18-month longitudinal Asia-Pacific study. (PubMed, Psychiatry Res) - "PP1M treatment resulted in significant improvements in clinical symptoms, functional recovery, and competitive employment over 18 months. The findings emphasize the need to address systemic barriers to employment while supporting sustained clinical and functional recovery to facilitate workforce reintegration for schizophrenia patients."

Journal • CNS Disorders • Psychiatry • Schizophrenia

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