Invega Hafyera (paliperidone palmitate extended-release 6-month injection) / J&J - LARVOL DELTA

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

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

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

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

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

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

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

EXPERIENCE WITH 6 MONTH- PALIPERIDONE PALMITATE IN A MENTAL HEALTH CENTER: DESCRIPTIVE STUDY IN REAL CLINICAL PRACTICE (EPA 2024) - "Recent studies with PP3M support a reduction in hospitalizations and emergency room visits compared to monthly paliperidone and aripiprazole or oral antipsychotics. The existing scientific evidence to date indicates that the application of PP6M is giving safe results in the first months of follow-up, with few side effects recorded, and a low rate of decompensations. This study based on data from real clinical practice in a CSM, despite the limitation due to the small sample size, obtains similar results consistent with those described in previous clinical trials."

Clinical • CNS Disorders • Pain • Psychiatry • Schizophrenia

EFFICACY AND TOLERABILITY OF HALF-YEARLY LONG ACTING INJECTABLE PALMITATE PALIPERIDONE AFTER 12 MONTHS FOLLOW-UP (EPA 2024) - "The inclusion criteria were a diagnosis of schizophrenia (based on the ICD-10 criteria), the start of treatment with Long Acting Injectable Paliperidone Palmitate six-monthly (previously with palmitate paliperidone monthly) , and the non-utilization of another neuroleptic treatment. In conclusion, this study suggests that switching from PP1M to PP6M in patients with recently diagnosed schizophrenia was associated with maintained clinical stability, good tolerability and improved patient satisfaction with treatment. These findings support the efficacy and clinical utility of PP6M as a convenient and effective treatment option for patients with schizophrenia."

Clinical • CNS Disorders • Psychiatry • Schizophrenia

Paliperidone palmitate 6-month formulation for the treatment of schizophrenia: a 14-month follow-up study (EPA 2024) - "There is extensive clinical trial evidence for the use of paliperidone palmitate 1-month (PP1M) and paliperidone palmitate 3-month (PP3M) formulations for maintaining treatment continuity and preventing relapses and risk of hospitalizations in patients with schizophrenia. In our study, we found that long-term treatment with paliperidone palmitate 6-month formulation is effective and well tolerated in clinical practice conditions."

CNS Disorders • Psychiatry • Schizophrenia

Descriptive study of 100 patients with a diagnosis of psychosis treated with Paliperidone Palmitate 6-Month Long-Acting Injectable. (EPA 2024) - "Introduction: Psychotic disorders are serious mental illnesses that require long-term antipsychotic treatment that provides sufficient efficacy, safety and therapeutic adherence. The present real clinical practice study shows that PP6M could be an effective and well tolerated treatment in patients with severe mental disorder, for patients diagnosed with psychosis, with a high rate of relapse prevention and high rates of compliance. Changing treatment from PP1M or PP3M to PP6M could help patients with severe mental disorder to normalize their lives and functionality."

Clinical • CNS Disorders • Mental Retardation • Psychiatry • Schizophrenia

Evaluating the 6-month formulation of paliperidone palmitate: a twice-yearly injectable treatment for schizophrenia in adults. (PubMed, Expert Rev Neurother) - "Paliperidone Palmitate is the only antipsychotic that has been developed in three different intramuscular long-acting injectable (LAI) dosing regimen: monthly (PP1M), quarterly (PP3M), and from 2020 also twice-yearly (PP6M). PP6M allows a longer dosing interval than any other LAI antipsychotics, potentially reducing nonadherence and disease relapses. In future, an increase in the prescription rates of PP6M is expected and real-world efficacy and tolerability studies will be conducted."

Journal • Review • CNS Disorders • Psychiatry • Schizophrenia

Relapse Rates With Paliperidone Palmitate in Adult Patients With Schizophrenia: Results for the 6-Month Formulation From an Open-label Extension Study Compared to Real-world Data for the 1-Month and 3-Month Formulations. (PubMed, Int J Neuropsychopharmacol) - P3 | "In a clinical trial setting, PP6M significantly delayed time-to-relapse and demonstrated lower relapse rates compared to PP3M and PP1M treatments in real-world settings among adult patients with schizophrenia."

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

Preliminary data from a 4-year mirror-image and multicentre study of patients initiating paliperidone palmitate 6-monthly long-acting injectable antipsychotic: the Paliperidone 2 per Year study. (PubMed, Ther Adv Psychopharmacol) - "PP6M was initiated after a median of 3-4 years on previous treatment: 146 (73%) from paliperidone palmitate 3-monthly, 37 (19%) from paliperidone palmitate 1-monthly and 17 (9%) from other antipsychotics. Patient and clinician preference for LAIs with longer dosing intervals was the main reason for PP6M initiation/switching resulting in high treatment persistence. Future data are needed to evaluate the full impact of PP6M in clinical practice."

Journal • CNS Disorders • Psychiatry • Schizophrenia

Comparative effectiveness study of paliperidone palmitate 6-month with a real-world external comparator arm of paliperidone palmitate 1-month or 3-month in patients with schizophrenia. (PubMed, Ther Adv Psychopharmacol) - "Additional confounds, such as greater illness severity and more frequent comorbidities and comedications in the ECA, were not fully controlled by the applied statistical methods. Future real-world studies directly comparing PP6M with PP3M/PP1M and adjusting for these confounders are warranted."

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

Efficacy and safety of paliperidone palmitate 6-monthly long-acting injectable in reduction of relapses in patients with schizophrenia: An Asian subgroup analysis of phase 3, randomized study. (PubMed, Medicine (Baltimore)) - P3 | "Consistent with the global study population, PP6M was noninferior to PP3M in preventing relapse in patients with schizophrenia from the Asia region. Findings suggest the possibility of switching from PP1M/PP3M to twice-yearly PP6M without loss of efficacy and with no unexpected safety concerns."

Journal • P3 data • CNS Disorders • Psychiatry • Schizophrenia

Cost-effectiveness analysis of monthly, 3-monthly, and 6-monthly long-acting injectable and oral paliperidone in adults with schizophrenia. (PubMed, J Manag Care Spec Pharm) - " For patients with schizophrenia stabilized with paliperidone ER, switching to LAI formulations was not cost-effective, suggesting the high drug costs for LAI may not justify the improved quality of life within 5 years. Among LAI formulations, PP6M was cost-effective over PP1M and PP3M."

Clinical • Cost effectiveness • HEOR • Journal • CNS Disorders • Psychiatry • Schizophrenia

Long-term Efficacy and Safety of Paliperidone 6-month Formulation: An Open-label 2-year Extension of a 1-year Double-blind Study in Adult Participants With Schizophrenia. (PubMed, Int J Neuropsychopharmacol) - P3 | "The relapse rate observed with PP6M during the 2-year OLE was low (3.9%). Clinical and functional improvements demonstrated in the DB study were maintained during OLE and no new safety concerns were identified."

Journal • CNS Disorders • Pain • Psychiatry • Schizophrenia

Cost-Utility Analysis of Long-Acting Injectable (1-, 3-, AND 6-MONTH INJECTION) and Oral Paliperidone in Adults with Stable Schizophrenia (ISPOR 2023) - "For adults with stable schizophrenia, LAI paliperidone formulations were not cost-effective compared to ER, suggesting the high drug costs for LAI may not justify the improved quality of life. Among LAI formulations, PP6M is cost-effective compared to PP1M and PP3M."

Clinical • HEOR • CNS Disorders • Psychiatry • Schizophrenia

Long-Term Efficacy and Safety of Paliperidone 6-Month Formulation: An Open-Label Extension of a Double-Blind Study in Adult Patients with Schizophrenia (SIRS 2023) - P3 | "Abstract Details This abstract is an open label extension of the phase 3 randomized, double-blind study which shows the long-term efficacy and safety of long acting injectable paliperidone palmitate 6-monthy in patients with schizophrenia. * Presenting Author First Name Last Name Affiliation Dean Najarian Janssen Scientific Affairs, LLC, Titusville, NJ, USA Ibrahim Turkoz Janssen Research & Development, LLC, Titusville, NJ, USA Silvana Galderisi University of Campania “Luigi Vanvitelli”, Naples, Italy Hector F. Lamaison Department of Psychiatry, National University of La Plata (UNLP), Buenos Aires, Argentina Piotr Zalitacz Head of Psychiatric Unit, Gorlice Specialist Hospital, Gorlice, Poland Suresh Aravind Janssen Research & Development, LLC, Titusville, NJ, USA Ute Richarz Janssen Research & Development-Cilag, Gubelstrasse, Zug, Switzerland 2Ute * Richarz * Janssen R&D, Cilag Int. Zug, Switzerland Consent of Release of Rights I have read and agree..."

Clinical • CNS Disorders • Schizophrenia