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:  Evaluation of paliperidone palmitate long-acting injectable antipsychotic therapy as an early treatment option in patients with schizophrenia. (Pubmed Central) -  Feb 7, 2021   
    P3
    Symptomatic and functional improvements were observed with PP1M/PP3M in patients with differing durations of schizophrenia, but the magnitude of the effects was greater in those with early illness vs chronic illness. These findings advocate implementation of PP1M and PP3M in all stages of schizophrenia, including early illness.
  • ||||||||||  Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J
    Journal:  Methylated PP2A stabilizes Gcn4 to enable a methionine-induced anabolic program. (Pubmed Central) -  Jan 20, 2021   
    Here methionine directs the conserved methyltransferase Ppm1 via its target phosphatase PP2A to selectively stabilize Gcn4. Through this, cells conditionally modify a major phosphatase to stabilize a metabolic master regulator and drive anabolism.
  • ||||||||||  Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
    Clinical, Retrospective data, Journal:  Defining "Adequately Treated": A Post Hoc Analysis Examining Characteristics of Patients with Schizophrenia Successfully Transitioned from Once-Monthly Paliperidone Palmitate to Once-Every-3-Months Paliperidone Palmitate. (Pubmed Central) -  Jan 15, 2021   
    P3
    After 4 months' PP1M treatment, PANSS and CGI-S scores were significantly lower and PSP scores significantly higher in randomized patients versus non-randomized patients (least squares means [95% CI]: 57.1 [55.7, 58.6] vs 62.2 [60.0, 64.3], 2.9 [2.8, 3.1] vs 3.3 [3.1, 3.4], and 67.0 [65.7, 68.3] vs 64.5 [62.6, 66.4], respectively); changes from baseline between groups differed significantly (all P ≤0.009). Confirming adequate stabilization with PP1M prior to transitioning to PP3M is critical in maximizing treatment response; clinicians should consider transitioning patients to PP3M only if patients respond well to PP1M for at least 4 months and their last two consecutive doses are the same.
  • ||||||||||  Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
    Journal:  Switching from clozapine to paliperidone palmitate-3-monthly improved obesity, hyperglycemia and dyslipidemia lowering antipsychotic dose equivalents in a treatment-resistant schizophrenia cohort. (Pubmed Central) -  Jan 15, 2021   
    In the last decade, new antipsychotics, such as paliperidone palmitate (PP), have emerged as well as its long acting-injectable (LAI) formulations, available as PP-1-monthly (PP1M) and the newest PP-3-montlhy (PP3M)...Antipsychotics and benzodiazepines dosages were compared using by the defined daily dose (DDD) method and haloperidol or diazepam dose equivalents...Switching clozapine to PP3M led to a significant lower pharmacological exposure to antipsychotics, by both the DDD (P < 0.05) and haloperidol dose equivalents (P < 0.001) methods without increasing the dose of benzodiazepines while biperiden was more used under PP3M...In conclusion, our findings suggest that switching clozapine to PP3M improved endocrine and hepatic profile with a lower total exposure to antipsychotics. More studies are needed to truly establish the role of PP3M in treatment-resistant schizophrenia and should be compared against clozapine by using clinical trials.
  • ||||||||||  Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
    Clinical, Journal:  Effect of Paliperidone Palmitate 3-Month Formulation on Goal Attainment and Disability After 52 Weeks' Treatment in Patients with Clinically Stable Schizophrenia. (Pubmed Central) -  Jan 2, 2021   
    The proportion of patients with remunerated work status increased by 11.3% at LOCF endpoint. The results of this secondary endpoint analysis indicate that continued treatment of patients with schizophrenia with PP3M following stabilization with PP1M may facilitate attainment of patients' personal goals and reduce disability, especially, but not exclusively, in patients with symptomatic remission achieved at LOCF.
  • ||||||||||  Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J
    [VIRTUAL] Oral antipsychotics versus monthly intramuscular paliperidone: a longitudinal pre-post design study evaluating the transition’s effects on healthcare utilization () -  Dec 26, 2020 - Abstract #ASHP2020ASHP_4151;    
    Excluded patients include patients with a maintenance dose of monthly intramuscular paliperidone within 6 months prior to the July 1, 2018- July 1, 2019 study window, patients < 18 years old, patients on other long acting injectable antipsychotics, and patients with no hospital utilization prior to start date. Secondary outcomes include insurance information, background/demographics, concomitant oral antipsychotic medications prior/after initiation of monthly intramuscular paliperidone, and reason for conversion off monthly intramuscular paliperidone (if applicable).
  • ||||||||||  Abilify Maintena (aripiprazole depot formulation) / Otsuka, Lundbeck
    Clinical, Journal, Real-World Evidence:  Second-generation long-acting injections anti-psychotics improve executive functions in patients with schizophrenia: a 12-month real-world study. (Pubmed Central) -  Dec 17, 2020   
    In comparison with the previous oral treatment with SGAs, patients showed a significant improvement in neurocognitive function after 12 months of treatment with SGA-LAI. Furthermore, there were no differences between the SGA-LAI regimens.Key pointsThe main purpose of this study was to assess possible modification of cognitive performance of patients with Schizophrenia treated with second generation long-acting injectable antipsychotics (SGA-LAIs).The secondary objective was to carry out a head to head comparison of two different SGA-LAIs: Paliperidone Palmitate 1-Month (PP1M) and Aripiprazole Monthly (Ari-LAI).Patients showed a significant improvement in neurocognitive function after 12 months of treatment with SGA-LAI.There were no differences between the SGA-LAI regimens.From a practical point of view, switching to LAI formulation seems to produce further social and cognitive improvements in patients who had already benefitted from oral SGA therapy.
  • ||||||||||  Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
    Journal, Interview:  "I live, I don't work, but I live a very normal life"-A qualitative interview study of Scandinavian user experiences of schizophrenia, antipsychotic medication, and personal recovery processes. (Pubmed Central) -  Dec 3, 2020   
    Furthermore, there were no differences between the SGA-LAI regimens.Key pointsThe main purpose of this study was to assess possible modification of cognitive performance of patients with Schizophrenia treated with second generation long-acting injectable antipsychotics (SGA-LAIs).The secondary objective was to carry out a head to head comparison of two different SGA-LAIs: Paliperidone Palmitate 1-Month (PP1M) and Aripiprazole Monthly (Ari-LAI).Patients showed a significant improvement in neurocognitive function after 12 months of treatment with SGA-LAI.There were no differences between the SGA-LAI regimens.From a practical point of view, switching to LAI formulation seems to produce further social and cognitive improvements in patients who had already benefitted from oral SGA therapy. The participants emphasize the importance of trustful relations with healthcare professionals, therapeutic conversations, antipsychotic medication in a 3-monthly formulation, and support from relatives.
  • ||||||||||  Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J
    Trial completion date, Trial primary completion date:  Oral Risperidone Versus Injectable Paliperidone Palmitate for Treating First-Episode Schizophrenia (clinicaltrials.gov) -  Nov 13, 2020   
    P4,  N=170, Active, not recruiting, 
    Trial primary completion date: Oct 2020 --> Mar 2021 Trial completion date: Dec 2020 --> Apr 2021 | Trial primary completion date: Dec 2020 --> Apr 2021
  • ||||||||||  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:  "Real world" clinical effectiveness of paliperidone palmitate 3-monthly injectable in early psychosis patients. (Pubmed Central) -  Sep 29, 2020   
    Pharmacy costs associated with switching nonadherent OAA patients with a recent relapse to PP1M were offset by reduced relapse rates and health care costs at years 1, 2, and 3, with earlier use of PP1M resulting in increased cost savings at all years. No abstract available
  • ||||||||||  Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Hafyera (paliperidone palmitate extended-release 6-month injection) / J&J
    Enrollment closed:  A Study of Paliperidone Palmitate 6-Month Formulation (clinicaltrials.gov) -  Sep 22, 2020   
    P3,  N=178, Active, not recruiting, 
    No abstract available Recruiting --> Active, not recruiting
  • ||||||||||  Abilify Maintena (aripiprazole depot formulation) / Otsuka, Lundbeck, Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J
    Trial completion:  EULAST: European Long-acting Antipsychotics in Schizophrenia Trial (clinicaltrials.gov) -  Sep 1, 2020   
    P4,  N=536, Completed, 
    Further research and analysis of subgroups are needed; however, these findings might be useful for clinicians. 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, PK/PD data, Journal:  Need for Bioequivalence Standards that Reflect the Clinical Importance of the Complex Pharmacokinetics of Paliperidone Palmitate Long-Acting Injectable Suspension. (Pubmed Central) -  Aug 11, 2020   
    We recommend that new Canadian standards be developed for multiphasic and biphasic intramuscular / subcutaneous (IM/SC) products, including paliperidone palmitate LAI products, because, similar to modified-release oral dosage forms, a different PK profile in modified-release IM/SC products can result in clinically meaningful differences in safety, efficacy, and tolerability. To ensure bioequivalence for both newly initiated and switch patients, this paper proposes bioequivalence standards that could be adopted in Canada that include two studies, a multiple-dose cross-over study, and a single-dose study with partial AUC metrics.
  • ||||||||||  Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J
    [VIRTUAL] Real-world effectiveness of aripiprazole long-acting injectable (Poster Area) -  Aug 5, 2020 - Abstract #ECNP2020ECNP_1177;    
    Conclusions The introduction of ALAI had a significant impact on the long term clinical outcomes in terms of reduced hospitalizations and high continuation rates due to favourable tolerability in this naturalistic cohort. Reductions in bed usage were similar to those reported for patients treated with once monthly Paliperidone Palmitate in the same clinical setting [3,4].
  • ||||||||||  Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J
    [VIRTUAL] A five-year follow up study of a naturalistic cohort treated with long-acting injectable antipsychotics (Poster Area) -  Aug 5, 2020 - Abstract #ECNP2020ECNP_1176;    
    The main purpose of this study was to establish the long-term effects of Paliperidone Palmitate (PP1M) on treatment continuation and hospital stay in a naturalistic setting...Benefits were well sustained into the fourth and fifth year of treatment with only a negligible number of patients dropping out or requiring hospital care. Our findings provide further support to the potential role of LAIs to enhance long lasting stability and recovery.
  • ||||||||||  risperidone / Generic mfg., Egis, Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, amisulpride / Generic mfg.
    [VIRTUAL] Paliperidone palmitate in an adult with Asperger ‘s syndrome (Poster Area) -  Aug 5, 2020 - Abstract #ECNP2020ECNP_999;    
    Oral paliperidone appears effective for the treatment of irritability in children, adolescents, and adults with AS.Aim:We report the first successful use of monthly paliperidone palmitate for the treatment of behavioral symptoms in an adult with AS...For several years different pharmacological approaches were tried, including risperidone, haloperidol, thioridazine, escitalopram, topiramate, clobazam and amisulpride, with unremitting behavioral symptoms...This case reports the successful use of paliperidone in its oral formulation, and maintenance of the remission of behavioral symptoms with an equivalent dose of its long-acting injectable formulation in an adult with AS. To the best of our knowledge, it is the first described case of paliperidone palmitate in an adult with AS and the results are compelling.
  • ||||||||||  risperidone / Generic mfg., Egis, Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
    [VIRTUAL] Paliperidone palmitate long-acting formulations in recent-onset psychosis: a retrospective, non-interventional study (Poster Area) -  Aug 5, 2020 - Abstract #ECNP2020ECNP_895;    
    Patients receiving 1-monthly and 3-monthly paliperidone palmitate formulations obtained greater improvements compared to the oral treatment group in main domains evaluated in the PANSS, general improvement in the PSP scale, and in overall CGI-I and CGI-S scales (p<0.001)...As previously mentioned, oral paliperidone or risperidone and paliperidone palmitate long-acting formulations were generally well tolerated. At final assessment, significant reductions were observed in the main clinical scales assessed, maintaining psychopathological stability throughout the 12-month evaluation for all groups, where an improvement in general psychosocial and global functioning was observed.
  • ||||||||||  Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
    [VIRTUAL] Comparison of possible safety risks on clinical trials between PP3M and PP1M (Poster Area) -  Aug 5, 2020 - Abstract #ECNP2020ECNP_890;    
    In the clinical trials, PP3M was required to be switched from PP1M after more than 4 months treatment and stabilized. Therefore, the incident rate of TEAEs of PP3M was same to lower compared to PP1M, and no new safety risks for PP3M were identified.
  • ||||||||||  Abilify Maintena (aripiprazole depot formulation) / Otsuka, Lundbeck, Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
    [VIRTUAL] From one-month to three-month paliperidone palmitate: an Italian real-world, retrospective, one-year mirror image study (Poster Area) -  Aug 5, 2020 - Abstract #ECNP2020ECNP_797;    
    Introduction A 3-months formulation of paliperidone palmitate injections (PP3M) was marketed in Italy in 2017, providing a useful treatment option for schizophrenic patients clinically stable with 1-month formulation (PP1M) [1]...Fifty per cent of the whole sample (53% of PP1Mp, 44% of PP3Mp) was already on a LAI prior to PP; 23% of the whole sample (24% of PP1Mp, 19% of PP3Mp) had been previously treated with Haloperidol depot, 11% (9% of PP1Mp, 13% of PP3Mp) with Fluphenazine depot, 10% (12% of PP1Mp, 6% of PP3Mp) with Risperidone depot, 8% (9% of PP1Mp, 6% of PP3Mp) with Zuclopenthixol depot, 2% (3% of PP1Mp and no PP3Mp) with Aripiprazole depot...Conclusions In the present sample PP3M efficacy was confirmed comparing pre-initiation and post-initiation 6-months time intervals: hospitalizations number significantly decreased, while the continuity of care was preserved. Studies about longer durations of therapy are necessary to support these preliminary data.
  • ||||||||||  Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J
    Clinical, Journal:  Partial compliance with long-acting paliperidone palmitate and impact on hospitalization: a 6-year mirror-image study. (Pubmed Central) -  Jun 19, 2020   
    These findings were similar in the subgroup of patients with schizophrenia who continued treatment for 3 years (n = 68). There was a direct association between partial compliance and re-hospitalisation; fully compliant patients maintained the best outcomes in terms of reduced bed use following PPM1 initiation.
  • ||||||||||  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
    Trial completion, Trial completion date:  A Study of Paliperidone Palmitate 6-Month Formulation (clinicaltrials.gov) -  Jun 17, 2020   
    P3,  N=841, Completed, 
    PP1M treatment appears to improve not only schizophrenic symptoms but also functional outcomes. Active, not recruiting --> Completed | Trial completion date: Aug 2020 --> May 2020
  • ||||||||||  Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
    PK/PD data, Journal:  Pharmacokinetic-Pharmacodynamic Characterization of Relapse Risk for Paliperidone Palmitate 1-Month and 3-Month Formulations. (Pubmed Central) -  Apr 22, 2020   
    This PK/PD analysis confirmed that PP1M and PP3M provide comparable efficacy in terms of relapse prevention, and that PP3M is superior to placebo. The PK/PD models presented here may as well be applied to studies with similar designs as either study A or B.