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

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

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

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

Model-Informed Clinical Development of Once-Every-6-Month Injection of Paliperidone Palmitate in Patients with Schizophrenia: A Pharmacometric Bridging Approach (Part I). (PubMed, Eur J Drug Metab Pharmacokinet) - P3 | "Consistency of the MIDD approach with observed clinical outcomes confirmed the hypothesis that lower Ctrough did not lead to increased relapse rates at the doses administered. Although higher paliperidone peak concentrations are achieved with corresponding doses of PP6M relative to PP3M in the phase-3 clinical study, types and incidences of treatment-related adverse events were comparable between PP6M and PP3M groups and no new safety concerns emerged for PP6M (Najarian et al. in Int J Neuropsychopharmacol 25(3):238-251, 2022)."

Journal • CNS Disorders • Psychiatry • Schizophrenia

Switching from paliperidone palmitate 3-monthly long-acting injection to oral aripiprazole in a pregnant woman with schizophrenia: a case report and short review. (PubMed, Riv Psichiatr) - "No obstetrical or fetal complications were reported. As the research in this field is very demanding, it would be precipitous to derive final conclusions from the current case report, but we hope to build a growing number of data that would allow us to make more appropriate and safe therapeutic choices in such a vulnerable phase as the peripartum."

Journal • Review • CNS Disorders • Obstetrics • Psychiatry • Schizophrenia

PALIPERIDONE 3-MONTH INJECTION IN VERY HIGH DOSAGES: CASE REPORTS (APA 2024) - "He used Haloperidol, Chlorpromazine, Risperidone, Clozapine throughout his life. In 2013, he began using monthly Paliperidone Palmitate (PP1M), initial dose of 150 mg/month (equivalent dose in the United States 234 mg)...He has already been treated with Aripiprazole, Risperidone, Quetiapine and Clozapine...Conclusion – PP3M is an antipsychotic that can be applied every 75 days or 90 days and has proven to be effective and safe in this group of patients. It proved to be an interesting alternative for cases of refractory Schizophrenia."

Case report • Clinical • CNS Disorders • Psychiatry • Schizophrenia • PRL

Variable doses, plasma levels and response relationship of one-month aripiprazole and three-month paliperidone in patients with severe schizophrenia. (APA 2024) - "Taking into account that there is no linear relationship between doses and PL, the effectiveness in people with severe schizophrenia of AOM and PP3M depends on reaching high PL, achieved with high doses but also with standard doses in some cases. And without thereby worse treatment tolerability, safety, or adherence."

Clinical • CNS Disorders • Movement Disorders • Parkinson's Disease • Psychiatry • Schizophrenia

Long term impact of 3-monthly paliperidone palmitate on hospitalisation in patients with schizophrenia: Six-year mirror image study. (PubMed, Acta Psychiatr Scand) - No abstract available

Journal • CNS Disorders • Psychiatry • Schizophrenia

Simulating different switch rates of once- monthly (PP1M) and once-every-3-months (PP3M) paliperidone palmitate to once-every-6-months paliperidone palmitate (PP6M) for the management of schizophrenia in Medicare: A budget impact model (BIM) (AMCP 2024) - "Increased switch rates from PP1M and PP3M to PP6M in Medicare for adults with schizophrenia are pro- jected to have minimal budget impact. Population health decision-makers who assess different treatment options for patients with schizophrenia can benefit more with this long-acting injectable antipsychotic with the longest dosing interval and may improve treatment adherence in patients with schizophrenia."

HEOR • Medicare • Reimbursement • US reimbursement • CNS Disorders • Psychiatry • Schizophrenia

Comparisons of the Treatment Discontinuation Rates Between Long-Acting Injectable Paliperidone 1-Month and 3-Months in a Nationwide Population Database (SIRS 2024) - "In light of this, LAI antipsychotics with extended durations of action have been developed and LAI paliperidone palmitate with a 3-month interval (PP3M) (Invega Trinza) has been introduced. We included 13,344 patients with schizophrenia who had been prescribed either LAI PP1M or LAI PP3M. The mean treatment duration was significantly longer in the PP3M group than in the PP1M group (t = -39.951, p < 0.001). A Cox proportional-hazards model indicated that LAI PP3M was associated with lower treatment discontinuation compared to LAI PP1M (HR=0.594, CI=0.557–0.633)."

Clinical • CNS Disorders • Schizophrenia

Clinical outcomes with paliperidone palmitate 3-monthly injection as monotherapy: observational 3-year follow-up of patients with schizophrenia. (PubMed, Eur Psychiatry) - "PP3M is a highly effective monotherapy treatment for reducing relapse in people with schizophrenia."

Clinical data • Journal • Monotherapy • CNS Disorders • Psychiatry • Schizophrenia

IMPORTANCE OF THE TYPE OF PHARMACOLOGICAL TREATMENT IN PATIENTS WITH SEVERE MENTAL DISORDER (EPA 2024) - " We select patients with different severe mental disorders who stay in a Medium Stay Unit, Sociosanitary Community Residence, Supervise house and Residence for the elderly in Albacete (Spain); all of them, with intramuscular neuroleptic treatment (zuclopenthixol dihydrochloride, aripiprazole long acting, palmitate paliperidone monthly, 3-monthly and 6-monthly) at least 1 year...31% of the patients with zuclopenthixol dihydrochloride treatment, have gone to psychiatric emergencies and 28% of psychiatric admissions in the last year.18% of the patients with aripiprazole long acting, 17% with paliperidone palmitate long acting-monthly and 12% de 3-monthly have gone to psychiatric emergencies and 15%, 12% and 12% needed psychiatric admissions respectively. - The longer long acting of the intramuscular treatments, the better patient satisfaction.- With the longer duration treatment (Palmitate paliperidone LD 6 month), we have lower psychiatric emergencies and hospital..."

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