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

Substance Misuse To Psychosis for Stimulants (clinicaltrials.gov) - P2/3 | N=165 | Completed | Sponsor: The University of Hong Kong | Recruiting ➔ Completed | N=240 ➔ 165

Enrollment change • Trial completion • CNS Disorders • Psychiatry • Schizophrenia

Long-Term Symptomatic and Functional Remission with Paliperidone Palmitate 6-Monthly Treatment in Schizophrenia: A 3-Year Post-Hoc Analysis. (PubMed, Neuropsychiatr Dis Treat) - P3 | "Long-acting injectable (LAI) formulations of paliperidone palmitate (PP) 1-month-(PP1M), 3-month-(PP3M), and 6-month-(PP6M) have been shown to delay time to relapse and to lower relapse rates, while maintaining symptomatic and functional improvements in patients with schizophrenia. In addition, >56% of patients who transitioned from PP3M to PP6M or continued PP6M treatment had sustained combined (symptomatic and functional) remission at the OLE endpoint. These findings support the long-term efficacy of PP3M and PP6M, highlighting the potential benefits of transitioning to longer acting antipsychotic formulations in achieving and sustaining both symptomatic stability and functional improvement in adults with schizophrenia."

Journal • Retrospective data • CNS Disorders • Psychiatry • Schizophrenia

Impacts of Taiwan's National Health Insurance Dedicated Budget Policy on Long-Acting Injectable Usage: An Interrupted Time-Series Analysis (CINP-AsCNP 2025) - "The impact of NHI reimbursement for SGA paliperidone palmitate once-monthly/3-monthly (R-PP1M/R-PP3M) on prescribing was also assessed. The LAI-DBP significantly increased the proportion of antipsychotic prescriptions using any LAI and SGA-LAIs and had a greater impact than R-PP1M and R-PP3M. LAI prescriptions account for approximately one-third of all antipsychotic prescriptions, suggesting that, in addition to financial support, other strategies may be needed to overcome obstacles to their uptake."

Reimbursement • US reimbursement • CNS Disorders • Psychiatry • Schizophrenia

Effectiveness of long-acting injectable paliperidone palmitate on relapse prevention of schizophrenia (CINP-AsCNP 2025) - "Background: Long-acting injectable (LAI) antipsychotics have been widely used in treating people with schizophrenia. Longer half-life of LAI antipsychotics may be more effective in relapse prevention of schizophrenia."

CNS Disorders • Psychiatry • Schizophrenia

Clinical Practice Recommendations for Switching to Longer-Interval Injectable Antipsychotics in Schizophrenia Patients: A Modified Delphi Study in China (CINP-AsCNP 2025) - "Furthermore, the benefits can be amplified in patients who switch from short-interval LAIs, such as paliperidone palmitate one-month formulation (PP1M), to longer-interval LAIs, such as paliperidone palmitate three-month formulation (PP3M) or six-month formulation (PP6M)[3-5]. The findings from the current result support the application of longer-interval LAIs for stable schizophrenia patients. The recommendations aim to optimize the use of longer-interval LAIs and are expected to enhance the outcomes for patients with schizophrenia in China."

Clinical • CNS Disorders • Mental Retardation • Psychiatry • Schizophrenia

One-Year Evaluation of Paliperidone Palmitate 6-Monthly: Satisfaction and Perceived Effectiveness Among Patients, Relatives, and Clinicians. (PubMed, Patient Prefer Adherence) - "Patient satisfaction and perceived treatment effectiveness play a critical role in healthcare outcomes and overall well-being. Patients, their carers and relatives as well as mental health professionals reported a high satisfaction rate with PP6M, and equally good or even better perceived effectiveness compared to PP1M, PP3M or other oral or LAIs antipsychotics in the majority of cases. Improved patient experience with PP6M could improve treatment continuity and reduce hospitalization rates."

Journal • CNS Disorders • Psychiatry • Schizophrenia

Psychiatric Challenges and Medication Management Following Bariatric Surgery: A Case Report on Bipolar I Disorder (APA 2025) - "Case Presentation The first patient, a 41-year-old Caucasian woman, was stabilized on a regimen that included oral Brexpiprazole at 2 mg, Buspirone at 30 mg twice daily, Mirtazapine at 45 mg, and intramuscular Invega Sustenna at 234 mg, which was later switched to Invega Trinza at 819 mg and Invega Hafyera at 1560 mg...A similar trajectory was observed in a 23-year-old female patient with comorbid generalized anxiety disorder and post-traumatic stress disorder, who was stabilized on Abilify Aristada administered every four weeks, along with sertraline at 150 mg, buspirone at 20 mg twice daily, and propranolol at 30 mg twice daily...Antipsychotic drugs, such as quetiapine and olanzapine, may experience altered bioavailability due to changes in gastrointestinal physiology and first-pass metabolism, causing variable therapeutic responses and a higher risk of adverse effects...The modifications in gastrointestinal structure and function, such as a decrease in gastric..."

Bariatric surgery • Case report • Clinical • Surgery • Bipolar Disorder • CNS Disorders • Gastrointestinal Disorder • General Anxiety Disorder • Mental Retardation • Post-traumatic Stress Disorder • Psychiatry

Achieving Stability With Dual Long Acting Injectable Antipsychotic Medications in Treatment Resistant Psychosis a Case Series (APA 2025) - "The LAIs used were Invega (paliperidone) and Abilify (aripiprazole) in three cases, and Invega and Haldol (haloperidol) in the other three...In the other cases, Invega Sustenna and Abilify Maintena were used simultaneously...The cases in this series highlight LAIs as an important psychopharmacological tool in managing psychosis and potentially transitioning patients out of acute care settings, where they may otherwise be held for weeks, months, or years at a time due to safety concerns and/or a lack of appropriate resources. Furthermore, three of these cases support the use of two second-generation antipsychotics in combination as LAIs, which may be necessary to avoid severe side effects and the effects of long-term use commonly associated with first-generation antipsychotics."

Clinical • Bipolar Disorder • CNS Disorders • Mental Retardation • Psychiatry • Schizophrenia

Real-World Adherence, Healthcare Resource Utilization, And Costs Among Patients With Schizophrenia Utilizing Once-Monthly, Once-Every-Three-Months, And Once-Every-Six-Months Paliperidone Palmitate in the United States (ISPOR 2025) - "OBJECTIVES: Once-every-6-months paliperidone palmitate (PP6M) is the longest dosing interval long-acting injectable (LAI) antipsychotic, followed by once-every-three-months paliperidone palmitate (PP3M). In this real-world descriptive study, patients with schizophrenia using PP3M or PP6M were more adherent, 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 medical costs."

Adherence • Clinical • HEOR • Real-world • Real-world evidence • CNS Disorders • Psychiatry • Schizophrenia

Treatment Persistence of Paliperidone Palmitate 3-Month in Patients With Schizophrenia: A Japan Medical Data Center Claims Database Analysis. (PubMed, Neuropsychopharmacol Rep) - "Treatment persistence rates for PP3M in Japan were relatively high among schizophrenia patients transitioned from PP1M. High persistence rates can be achieved with PP3M monotherapy in patients who have been sufficiently stabilized with PP1M monotherapy prior to initiating PP3M."

Journal • Retrospective data • CNS Disorders • Psychiatry • Schizophrenia

An analysis of the clinical application of paliperidone palmitate injection based on real-world. (PubMed, Front Pharmacol) - "5 (9.09%) patients were switched from risperidone long-acting injection (RLAI) to PP1M. Patients with initial episodes with and adhering to PP injection were at lower risk of relapse. Thus, the patients' adherence and the education about PP injections should be improved."

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

Long-term effectiveness, adherence and safety of twice-yearly paliperidone-palmitate long acting-injectable in patients with schizophrenia in Europe: 2-year mirror-image data from the paliperdone-2 per year study (P2Y). (PubMed, Front Psychiatry) - "The majority of patients had switched to PP6M from either PP3M (76%) or PP1M (19%) while the 3% switched from aripiprazole 1-monthly and the 2% from risperidone-LAI and zuclopenthixol-LAI. Nonetheless, we were unable to determine the precise changes in symptoms. Therefore, future studies are needed to truly establish the role of PP6M."

Journal • CNS Disorders • Psychiatry • Schizophrenia

Dynamics of Clinical Manifestations and Social Functioning in Schizophrenia: A Non-interventional Observational Study of Paliperidone Palmitat Dosage Forms. (PubMed, Consort Psychiatr) - "Treatment with different forms of paliperidone provides a roughly equal pace reduction in the severity of schizophrenia, including positive and negative symptoms. The PP3M group had better adherence and the highest number of patients who fully completed the study."

Journal • Observational data • CNS Disorders • Psychiatry • Schizophrenia

Alkermes plc Reports Financial Results for the Fourth Quarter and Year Ended Dec. 31, 2024 and Provides Financial Expectations for 2025 (PRNewswire) - "Royalty revenues from XEPLION, INVEGA TRINZA/TREVICTA and INVEGA HAFYERA/BYANNLI for the fourth quarter were $36.5 million. VUMERITY manufacturing and royalty revenues for the fourth quarter were $35.0 million. FAMPYRA manufacturing and royalty revenues for the fourth quarter were $22.9 million. The company does not expect to record any FAMPYRA revenue going forward. RISPERDAL CONSTA manufacturing revenues for the fourth quarter were $14.7 million."

Commercial • Bipolar Disorder • CNS Disorders • Multiple Sclerosis • Schizophrenia

Comparing two transitioning strategies to paliperidone palmitate once-every-6-months. (PubMed, CNS Spectr) - P3 | "Adults with schizophrenia who transitioned to PP6M from either PP1M or PP3M experienced similarly low relapse rates. Additionally, symptom and functionality scores supported the primary analysis and, along with TEAE incidences, were comparable between transition groups."

Journal • CNS Disorders • Psychiatry • Schizophrenia

Health-Care Utilisation and Costs of Transition from Paliperidone Palmitate 1-Monthly to 3-Monthly Treatment for Schizophrenia: A Real-World, Retrospective, 24-Month Mirror-Image Study. (PubMed, Neuropsychiatr Dis Treat) - "Moreover, significant reductions were noted in emergency room visits (PP1M vs PP3M: 0.3 vs 0.0, respectively; p = 0.05) and health-care costs (PP1M vs PP3M: 107,328.8 vs 57,848.6, respectively; p = 0.03). PP3M may significantly reduce hospitalisation duration, emergency room visits, and health-care costs in patients with schizophrenia."

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

A patient developed side effects after a paliperidone palmitate 3-monthly depot injection without proper tolerability assessment (ECNP 2024) - "It is recommended that patients be treated with once-monthly paliperidon palmitate (PP1M) for at least 4 months before switching to PP3M[4].A 44-year-old male patient, with atypical psychosis since 2013, was admitted to the emergency department in February 2024 with symptoms of dystonia and dysphagia. In his last visit, biperiden was decreased to 6 mg/day and 400 mg/day of carbamazepine, 75 mg/day of venlafaxine, and 3 mg/day of clonazepam were continued. His last BPRS score was 6 and UKU-SERS score was 2.With this case report, we would like to draw attention to inconvenience of switching to long-acting forms of antipsychotics in the patient before the tolerability of the antipsychotic dose is not evaluated, and the tolerability can not be evaluated correctly with the active use of diazepam and biperiden, and the use of multiple antipsychotics such as olanzapine and paliperidone combination could not be suitable for a patient."

Adverse events • Clinical • CNS Disorders • Dystonia • Mood Disorders • Pain • Psychiatry

Therapeutic drug monitoring of long-acting injectable antipsychotics and psychopathological assessment in schizophrenia spectrum disorders: a longitudinal characterisation of relapse risk (ECNP 2024) - "LAI antipsychotics were aripiprazole (41.3%), olanzapine pamoate (26.1%), paliperidone palmitate once monthly (13.0%), paliperidone palmitate every 3 months (19.6%)... The present study suggests a role for TDM in real-world practice, as finding under-range LAI plasma levels in clinically stable outpatients may prompt monitoring for relapses especially in younger patients. Moreover, the study suggests that relapses in patients with adequate LAI antipsychotic plasma levels may be tied to worse affective and negative symptoms, and to a worse subjective experience of treatment - underlining the need for a thorough psychopathological assessment beyond psychotic symptoms."

Bipolar Disorder • CNS Disorders • Depression • Mood Disorders • Psychiatry • Schizophrenia

A multicentre, four-year mirror-image study comparing the effectiveness of long-acting injectable antipsychotics in the treatment of bipolar disorder (ECNP 2024) - "This was a 4-year mirror-image study of adult patients diagnosed with BD assessing the effects on treatment continuation and hospitalisation between aripiprazole 1-monthly (A1M), risperidone-LAI (R-LAI) and the 1-monthly and 3-monthly formulations of paliperidone palmitate (PP1M, PP3M)...The most prescribed benzodiazepine was lorazepam (29%) followed by clonazepam (21%) and the most prescribed mood stabilizer was lithium (63%) followed by valproate (31%). Overall, quetiapine was the most frequently prescribed oral antipsychotic (24%), followed by olanzapine (23%) and risperidone (23%)... 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. Among the different options, R-LAI performed the worst, possibly driven by the high discontinuation rates. Continued development of long and longer-acting antipsychotic treatments,..."

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

Real clinical experience with 6-monthly paliperidone palmitate in schizophrenia after 2 years of use (ECNP 2024) - "The present study shows that 6-monthly paliperidone palmitate has an excellent relapse prevention rate in patients with schizophrenia, which is similar to that reported in other published studies [1]. In addition, the rate of adherence to treatment was very high (100% of administrations within the expected time). On the other hand, both the switch to 6-monthly paliperidone palmitate from 1-monthly paliperidone palmitate and from 3-monthly paliperidone palmitate was safe and well tolerated, with no adverse effects."

Clinical • CNS Disorders • Psychiatry • Schizophrenia

Real clinical experience of 6-monthly paliperidone palmitate in severe mental illness after 2 years of use (ECNP 2024) - "Three of them presented psychotic decompensation due to the abandonment of oral medication (clozapine, lithium and risperidone) and two of them due to a relapse in the consumption of substances of abuse (mephedrone in one case and cocaine, heroin and cannabis in the other case). The present study shows high efficacy and tolerability of 6-monthly paliperidone palmitate in the treatment of various diagnoses of severe mental illness. Its high efficacy and tolerability, as well as the high adherence rate, make 6-monthly paliperidone palmitate a first-line option for the treatment of patients with severe mental illness. By the Results objectified in this real clinical practice study, 6-monthly paliperidone palmitate could help patients with severe mental illness to improve their functionality and normalize their lives."

Clinical • CNS Disorders • Psychiatry

Clinical effectiveness of paliperidone palmitate 3-monthly and 1-monthly as monotherapy in patients with schizophrenia: A retrospective cohort study based on the Medicaid claims database. (PubMed, Neuropsychopharmacol Rep) - "Findings suggests that patients who switched to PP3M might be able to reduce risk of relapse compared to those who continued PP1M after aligning particularly with Japan's label requirements."

Claims database • Journal • Medicaid • Monotherapy • Reimbursement • Retrospective data • US reimbursement • CNS Disorders • Psychiatry • Schizophrenia

Treatment persistence of paliperidone palmitate 3-month in patients with schizophrenia -an analysis of Japan Medical Data Center Claims Database (CINP 2024) - No abstract available

Claims database • Clinical • CNS Disorders • Psychiatry • Schizophrenia

CASPAR: A Study to Assess the Treatment of Schizophrenia With Paliperidone Palmitate in Rwandan Healthcare Settings (clinicaltrials.gov) - P4 | N=93 | Completed | Sponsor: Janssen-Cilag International NV | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Psychiatry • Schizophrenia

Model-Informed Clinical Development of 6-Monthly Injection of Paliperidone Palmitate in Patients with Schizophrenia: Dosing Strategies Guided by Population Pharmacokinetic Modeling and Simulation (Part II). (PubMed, Eur J Drug Metab Pharmacokinet) - P3 | "Paliperidone concentration-time profiles after PP6M and PP3M dosing were adequately described by the popPK model. Model-based simulation results provide guidance for clinicians on initiating PP6M therapy, transitioning between paliperidone formulations, the dosing windows to use for maintenance dosing, and managing missed PP6M doses."

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