Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J 
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  • ||||||||||  Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
    Clinical, Journal:  Clinical management of medication overdose: Three-monthly paliperidone palimitate injectable medication. (Pubmed Central) -  Apr 23, 2022   
    In patients stabilised on PP1M and switched to PP3M in normal clinical practice, rehospitalisation is very uncommon and much reduced compared with previous treatments. No abstract available
  • ||||||||||  Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
    Journal, HEOR:  Effectiveness and Quality of Life with Paliperidone Palmitate 3-Monthly in Comparison with Other Long-Acting Drugs. (Pubmed Central) -  Apr 21, 2022   
    HAL-D, PP1M and PP3M 1-year treatments were similarly effective in preventing relapses and improving quality of life and health satisfaction. All discontinuations in the new 3-monthly antipsychotic treatment were caused by patient refusal to continue it.
  • ||||||||||  Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J
    Retrospective data, Journal, HEOR:  A health economics study of long-acting injectable once-monthly paliperidone palmitate in schizophrenia: a one-year mirror-image study in China. (Pubmed Central) -  Apr 12, 2022   
    The observed reduction in the number of hospitalizations (t = 2.56, P ≤ 0.01) and inpatient stays (t = 1.73, P < 0.05) and after transition to PP1M resulted in a reduction in hospitalization costs (P < 0.01).Switching from OAPs to PP1M decreased the household workforce burden without increasing clinical healthcare costs. Direct costs were significantly reduced in patients with ≥ 1 inpatient stay in 1 year pre-PP1M treatment with OAPs after the switch, which decreased by improving adherence to therapy and reducing the number and length of hospital stays, suggesting that those patients may benefit after switching to PP1M.
  • ||||||||||  Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J
    Trial completion, Trial primary completion date:  Oral Risperidone Versus Injectable Paliperidone Palmitate for Treating First-Episode Schizophrenia (clinicaltrials.gov) -  Apr 11, 2022   
    P4,  N=146, Completed, 
    Direct costs were significantly reduced in patients with ≥ 1 inpatient stay in 1 year pre-PP1M treatment with OAPs after the switch, which decreased by improving adherence to therapy and reducing the number and length of hospital stays, suggesting that those patients may benefit after switching to PP1M. Trial primary completion date: May 2021 --> Dec 2021 | Active, not recruiting --> Completed
  • ||||||||||  Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
    Clinical, Journal:  New approaches to antipsychotic medication adherence - safety, tolerability and acceptability. (Pubmed Central) -  Mar 23, 2022   
    Novel pharmacological delivery methods included different routes of administration of registered medications (such as intramuscular clozapine preparation and transdermal asenapine), modifications of existing compounds (such as 3-monthly injectable formulation of paliperidone palmitate), and increased interest in oral long-acting medication formulations (such as with penfluridol)...The place of each approach is predicated on a personalized approach in each patient and future research could usefully use large comparative studies to establish robust treatment guidelines. The implementation of new and varied approaches to antipsychotic treatment adherence are welcome and have the potential to make a significant impact on morbidity in this often difficult- to- treat population.
  • ||||||||||  Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Hafyera (paliperidone palmitate extended-release 6-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
    Comparing Alternative Paliperidone Formulations for Relapse Prevention in Patients with Schizophrenia: A Cost-Utility Analysis (Virtual) -  Mar 8, 2022 - Abstract #ISPOR2022ISPOR_214;    
    Among paliperidone LAIs, PP3M has a preferable economic value over PP1M and PP6M. However, this conclusion is drawn based on results from clinical trials and might not be generalizable to real-world settings.
  • ||||||||||  Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Risperdal Consta (risperidone depot formulation) / J&J
    Enrollment closed, Enrollment change:  Observational Study of Long Acting Injectable Medications (LAIs) in Schizophrenia (OASIS) (clinicaltrials.gov) -  Feb 14, 2022   
    P=N/A,  N=338, Active, not recruiting, 
    Our results show that paliperidone plasma concentrations over injection doses may be associated with patterns of clinical response suggesting potential utility of TDM as part of PP1M-based maintenance treatment. Recruiting --> Active, not recruiting | N=1000 --> 338
  • ||||||||||  Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J
    PK/PD data, Journal, Adverse drug reaction:  Pharmacokinetic Correlates of Once-Monthly Paliperidone Palmitate-Related Adverse Drug Reactions. (Pubmed Central) -  Jan 28, 2022   
    Our findings did not reveal distinct patterns of paliperidone concentrations in patients with PP1M-related ADRs. However, male patients receiving PP1M every 28 days with C/D values higher than 7.7 (ng/mL)/(mg/day) showed a higher risk for ADRs, implying that therapeutic drug monitoring may be useful in assessing the risk of PP1M-related ADRs.
  • ||||||||||  Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
    Clinical, Journal, Real-world evidence:  Evaluation of long-acting injectable antipsychotics with the corresponding oral formulation in a cohort of patients with schizophrenia: a real-world study in Spain. (Pubmed Central) -  Dec 25, 2021   
    We evaluated the use of LAIs antipsychotics [aripiprazole-1-month (A1M); paliperidone-1-month and 3-month (PP1M and PP3M) and biweekly (2w)-LAIs] and their corresponding oral formulations through (1) the number of hospital re-admissions, (2) the number of documented suicidal behaviour/attempts and (3) the use of concomitant benzodiazepines, oral antipsychotics and biperiden...Our results showed that LAIs associated significantly lower suicidal behaviour, reduced the number of hospital admissions, lower diazepam and haloperidol equivalents and mean daily dose of biperiden intake versus oral antipsychotics...In conclusion, LAIs improved clinical outcomes by reducing the need for concomitant treatments and hospital admissions over oral antipsychotics. PP1M and PP3M showed better outcomes versus A1M and biweekly LAIs.
  • ||||||||||  Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J
    Journal:  Long-acting injectable antipsychotics: what, when, and how. (Pubmed Central) -  Dec 25, 2021   
    Available LAI formulations in the United States include first-generation antipsychotics (fluphenazine decanoate and haloperidol decanoate), risperidone/paliperidone containing products (risperidone microspheres, paliperidone palmitate, and risperidone subcutaneous), aripiprazole containing products (aripiprazole monohydrate and aripiprazole lauroxil), and olanzapine pamoate...Differences and similarities among the different products are discussed, including guidance regarding optimal treatment selection. Tips are provided to enhance effective patient communication to maximize the likelihood of acceptance of this treatment modality.
  • ||||||||||  Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
    Clinical, Journal, Real-world evidence:  Off-label use of second-generation antipsychotics in borderline personality disorder: a comparative real-world study among oral and long-acting injectables in Spain. (Pubmed Central) -  Dec 25, 2021   
    The aim of the present study was to evaluate the use of oral vs. long-acting injectables (LAIs) antipsychotics, as well as, to compare the effectiveness of different LAI antipsychotics [aripiprazole-1-month, paliperidone-1-month (PP1M), paliperidone-3-month (PP3M) and risperidone long-acting injectable (RLAI)] in patients diagnosed with borderline personality disorder (BPD), by evaluating the following clinical outcomes: (1) the number of hospital admissions; (2) the number of documented suicidal behaviour/attempts; and (3) the use of concomitant treatments, including benzodiazepines, oral antipsychotics and biperiden...Moreover, PP1M and PP3M used lower daily dose of diazepam equivalents compared with the aripiprazole-1-month and RLAI treatment groups. In conclusion, the use of LAIs may play a role in the management of BPD.
  • ||||||||||  Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Hafyera (paliperidone palmitate extended-release 6-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
    Efficacy, Safety and Pharmacokinetics of Paliperidone Palmitate 6-Month Long-Acting Injectable in Patients With Schizophrenia: A Randomized, Double-Blind, Multicenter, Noninferiority Phase 3 Study ([VIRTUAL]) -  Nov 28, 2021 - Abstract #ACNP2021ACNP_937;    
    PK data from the current study as well as the PopPK simulations of concentration-time profiles indicated paliperidone plasma exposures were similar when switching from PP1M (after ≥4 months of treatment) or PP3M (after ≥1 cycle) to PP6M. Thus, PP6M provides consistent medication coverage with just two injections per year and may offer a viable option for maintenance treatment in cases where minimizing the frequency of injections can help meet treatment needs (e.g., patients with limited access to healthcare or medication adherence issues).
  • ||||||||||  Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Hafyera (paliperidone palmitate extended-release 6-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
    Efficacy, Safety and Pharmacokinetics of Paliperidone Palmitate 6-Month Long-Acting Injectable in Patients With Schizophrenia: A Randomized, Double-Blind, Multicenter, Noninferiority Phase 3 Study (Exhibit Hall C) -  Nov 28, 2021 - Abstract #ACNP2021ACNP_642;    
    PK data from the current study as well as the PopPK simulations of concentration-time profiles indicated paliperidone plasma exposures were similar when switching from PP1M (after ≥4 months of treatment) or PP3M (after ≥1 cycle) to PP6M. Thus, PP6M provides consistent medication coverage with just two injections per year and may offer a viable option for maintenance treatment in cases where minimizing the frequency of injections can help meet treatment needs (e.g., patients with limited access to healthcare or medication adherence issues).
  • ||||||||||  Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
    Journal:  Factors predicting relapse and treatment discontinuation with paliperidone: 3-monthly long-acting injection - a two-year naturalistic follow-up study. (Pubmed Central) -  Nov 24, 2021   
    Thus, PP6M provides consistent medication coverage with just two injections per year and may offer a viable option for maintenance treatment in cases where minimizing the frequency of injections can help meet treatment needs (e.g., patients with limited access to healthcare or medication adherence issues). Post hoc we examined outcomes in those switched back to one monthly paliperidone (PP1M) long-acting injection...No abstract available
  • ||||||||||  paliperidone palmitate ER (LY03010) / Luye Group
    Enrollment closed, Trial completion date:  Relative Bioavailability of LY03010 Compared to Listed Drug (clinicaltrials.gov) -  Nov 22, 2021   
    P1,  N=281, Active, not recruiting, 
    Post hoc we examined outcomes in those switched back to one monthly paliperidone (PP1M) long-acting injection...No abstract available Recruiting --> Active, not recruiting | Trial completion date: Jan 2022 --> Apr 2022
  • ||||||||||  Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
    Journal:  Transitioning from Once-Monthly to Once-Every-3-Months Paliperidone Palmitate Among Veterans with Schizophrenia. (Pubmed Central) -  Oct 29, 2021   
    Increased all-cause pharmacy costs with PP3M were offset by reduced all-cause medical costs, resulting in overall health care cost-neutrality. Relative to those remaining on PP1M, VHA patients with schizophrenia who transitioned to PP3M experienced improved antipsychotic medication adherence and significantly shorter all-cause inpatient LOS; costs remained neutral.
  • ||||||||||  Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J
    Trial completion date:  Oral Risperidone Versus Injectable Paliperidone Palmitate for Treating First-Episode Schizophrenia (clinicaltrials.gov) -  Oct 28, 2021   
    P4,  N=170, Active, not recruiting, 
    Relative to those remaining on PP1M, VHA patients with schizophrenia who transitioned to PP3M experienced improved antipsychotic medication adherence and significantly shorter all-cause inpatient LOS; costs remained neutral. Trial completion date: Apr 2021 --> Dec 2021