Invega Hafyera (paliperidone palmitate extended-release 6-month injection) News

|||||||||| 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
PK/PD data, Journal: 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 Central) - May 20, 2024
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.

|||||||||| 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
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) () - Apr 9, 2024 - Abstract #AMCP2024AMCP_91;
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.

|||||||||| 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
Review, Journal: Evaluating the 6-month formulation of paliperidone palmitate: a twice-yearly injectable treatment for schizophrenia in adults. (Pubmed Central) - Mar 12, 2024
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.

|||||||||| 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
Clinical, Journal, Real-world evidence, Real-world: 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 Central) - Feb 19, 2024
P3
In future, an increase in the prescription rates of PP6M is expected and real-world efficacy and tolerability studies will be conducted. In a clinical trial setting, PP6M significantly delayed time to relapse and demonstrated lower relapse rates compared with PP3M and PP1M treatments in real-world settings among adult patients with schizophrenia.

|||||||||| 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
Journal: 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 Central) - Dec 28, 2023
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.

|||||||||| 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
Journal, HEOR, Real-world evidence, Real-world: 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 Central) - Oct 3, 2023
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.

|||||||||| 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
P3 data, Journal: 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 Central) - Sep 1, 2023
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.

|||||||||| 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
Clinical, Journal, HEOR, Cost-effectiveness, Cost effectiveness: Cost-effectiveness analysis of monthly, 3-monthly, and 6-monthly long-acting injectable and oral paliperidone in adults with schizophrenia. (Pubmed Central) - Aug 7, 2023
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.

|||||||||| Invega Hafyera (paliperidone palmitate extended-release 6-month injection) / J&J
Journal: 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 Central) - Jul 22, 2023
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.

|||||||||| 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
P3 data, Retrospective data, Journal, Head-to-Head: Efficacy and Safety of Paliperidone Palmitate 6-Month versus Paliperidone Palmitate 3-Month Long-Acting Injectable in European Patients with Schizophrenia: A Post Hoc Analysis of a Global Phase-3 Double-Blind Randomized Non-Inferiority Study. (Pubmed Central) - Apr 20, 2023
P3
The efficacy of PP6M was non-inferior to that of PP3M in preventing relapse in the European subgroup previously treated with PP1M or PP3M, which was consistent with the global study. No new safety signals were identified.

|||||||||| Invega Hafyera (paliperidone palmitate extended-release 6-month injection) / J&J
Review, Journal: The Effect of Longer Dosing Intervals for Long-Acting Injectable Antipsychotics on Outcomes in Schizophrenia. (Pubmed Central) - Mar 15, 2023
By eliminating the need for daily oral antipsychotic dosing, LAIs could increase the likelihood of patient acceptance, decrease stigma, and promote self-esteem. Longer intervals of medication coverage may be desirable for patients with higher risk of relapse including adults with recent-onset schizophrenia, those living in circumstances that may deprive them of regular access (eg, homeless), those that are in transitions between care settings or to reduce interpersonal contact during public health emergencies (eg, COVID-19 pandemic).

|||||||||| Invega Hafyera (paliperidone palmitate extended-release 6-month injection) / J&J
Long-Term Efficacy and Safety of Paliperidone 6-Month Formulation: An Open-Label Extension of a Double-Blind Study in Adult Patients with Schizophrenia () - Mar 10, 2023 - Abstract #SIRS2023SIR_770;
P3
Longer intervals of medication coverage may be desirable for patients with higher risk of relapse including adults with recent-onset schizophrenia, those living in circumstances that may deprive them of regular access (eg, homeless), those that are in transitions between care settings or to reduce interpersonal contact during public health emergencies (eg, COVID-19 pandemic). No deaths were reported during this study.Discussion The relapse rate with LAI PP6M, administered twice-yearly, was very low (<4%).Clinical improvements in PANSS, CGI-S, and PSP scales demonstrated in the DB study weremaintained during this 2-year OLE study and no new safety concerns were identified.KeywordKeywordsLong-acting injectablePaliperidone palmitate 6-monthPaliperidone palmitate 3-monthSchizophreniaRelapsePoster Award NoPlease list all co-authors for this poster submission.* Presenting AuthorFirst Name Last Name AffiliationDean Najarian Janssen Scientific Affairs, LLC,Titusville, NJ, USAIbrahim Turkoz Janssen Research & Development,LLC, Titusville, NJ, USASilvana Galderisi University of Campania

|||||||||| Invega Hafyera (paliperidone palmitate extended-release 6-month injection) / J&J
Cost-Utility Analysis of Long-Acting Injectable (1-, 3-, AND 6-MONTH INJECTION) and Oral Paliperidone in Adults with Stable Schizophrenia () - Mar 9, 2023 - Abstract #ISPOR2023ISPOR_940;
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.

|||||||||| 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
Journal, HEOR: Budget impact of introducing once-every-6-months paliperidone palmitate in US health care plans. (Pubmed Central) - Mar 2, 2023
Aditya Raju was an employee of Xcenda at the time of the development and finalization of the manuscript, and Danmeng Huang is an employee of Xcenda, a health care consulting firm that was contracted by Janssen Scientific Affairs, LLC. Chih-Yuan Cheng is an employee of Janssen NV.

|||||||||| Invega Hafyera (paliperidone palmitate extended-release 6-month injection) / J&J
Long-term efficacy and safety of paliperidone 6-month formulation: An open-label extension of a double-blind study in adult patients with schizophrenia (08. Room Passy) - Mar 2, 2023 - Abstract #EPA2023EPA_580;
P3
Relapse rate with PP6M was very low (<4%). Clinical improvements in PANSS, CGI-S, and PSP scales demonstrated in DB study were maintained during this 2-year OLE study and no new safety concerns were identified.

|||||||||| Invega Hafyera (paliperidone palmitate extended-release 6-month injection) / J&J
Journal: Changes in maternal and paternal body composition during the transition to parenthood (TRANSPARENTS). (Pubmed Central) - Dec 7, 2022
These changes were observed from the beginning of pregnancy up to 6 months post partum. Weight management for both women and men during pregnancy and the early postpartum period is recommended and fathers should be included in pre- and postnatal standard care.

|||||||||| 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
Journal, HEOR: Projecting the economic outcomes of switching patients with schizophrenia from oral atypical antipsychotics to once-monthly, once-every-3-months, and once-every-6-months paliperidone palmitate. (Pubmed Central) - Nov 16, 2022
Ms Morrison, Ms Ghelerter, Ms Vermette-Laforme, Mr Lefebvre, and Mr Pilon are employees of Analysis Group, Inc., a consulting company that has provided paid consulting services to Janssen Scientific Affairs, LLC., which funded the development and conduct of this study and manuscript. Dr Lin and Ms Benson are employees of Janssen Scientific Affairs, LLC., and stockholders of Johnson & Johnson.

|||||||||| 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
Paliperidone palmitate 6-month long-acting injectable in patients with schizophrenia from latin american countries: subgroup analysis from randomized double-blind phase-3 study (Poster area [IN-PERSON]) - Oct 13, 2022 - Abstract #ECNP2022ECNP_1196;
Findings suggest that it is possible to switch from PP1M or PP3M to PP6M without loss of efficacy. The safety profile of PP6M was similar to PP3M and no unexpected safety concerns were identified in the LA 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
Efficacy and safety of paliperidone palmitate 6-month versus paliperidone palmitate 3-month long-acting injectable in patients with schizophrenia in Europe (Poster area [IN-PERSON]) - Oct 13, 2022 - Abstract #ECNP2022ECNP_828;
P3
The Result s of this sub-group analysis were consistent with the findings of global study [4]. Conclusion : PP6M demonstrated non-inferior efficacy to PP3M in patients with schizophrenia in Europe, as observed in the global study. Safety Result s for PP6M were consistent with the known profile of paliperidone and were indistinguishable from the safety profile of PP3M.

|||||||||| 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
Patient satisfaction with 6-monthly versus 3-monthly paliperidone palmitate long-acting injectable for schizophrenia treatment – results from a phase-3, randomised, noninferiority study (Poster area [IN-PERSON]) - Oct 13, 2022 - Abstract #ECNP2022ECNP_653;
P3
These improvements were seen for both PP6M and PP3M. These findings provide patient-relevant information reinforcing the benefits of LAIs for schizophrenia treatment. Table.

|||||||||| 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
Patient Satisfaction With 6-Monthly Versus 3-Monthly Paliperidone Palmitate Long-Acting Injectable for Schizophrenia Treatment: Results From a Phase-3, Randomised, Noninferiority Study (In-person; Virtual) - Sep 1, 2022 - Abstract #ISPOREU2022ISPOR_EU_1047;
P3
Patients switching from oral antipsychotic treatments to long-acting injectables (LAIs) PP6M or PP3M showed improvement in measures of treatment satisfaction and satisfaction with social roles. These findings provide patient-relevant information reinforcing the benefits of LAIs for schizophrenia treatment.

||||||||||  Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Hafyera (paliperidone palmitate extended-release 6-month injection) / J&J
Trial completion:  A Study of Paliperidone Palmitate 6-Month Formulation (clinicaltrials.gov) -  Jun 22, 2022
P3, N=178, Completed,  Sponsor: Janssen Research & Development, LLC
These findings provide patient-relevant information reinforcing the benefits of LAIs for schizophrenia treatment. Active, not recruiting --> Completed

|||||||||| Invega Hafyera (paliperidone palmitate extended-release 6-month injection) / J&J
Clinical, Journal: Distribution characteristics of intestinal microbiota during pregnancy and postpartum in healthy women. (Pubmed Central) - Jun 22, 2022
Therefore, the diversity and function of the gut microbiota in healthy pregnant women remained unchanged during pregnancy; however, the composition of the intestinal microbiota in the postpartum period changed significantly. Our results provide the basis for in-depth studies of the composition of perinatal gut microbial communities in women.

|||||||||| 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
Clinical, Journal, Head-to-Head: A randomized, double-blind, multicenter, noninferiority study comparing paliperidone palmitate 6-month versus the 3-month long-acting injectable in patients with schizophrenia. (Pubmed Central) - May 7, 2022
P3
Our results provide the basis for in-depth studies of the composition of perinatal gut microbial communities in women. The efficacy of twice-yearly dosing regimen of PP6M was noninferior to that of PP3M in preventing relapse in patients with schizophrenia adequately treated with PP1M or PP3M.

|||||||||| 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
Budget Impact of Introducing Once-Every-Six-Months Paliperidone Palmitate for the Management of Schizophrenia Among Medicaid Beneficiaries in Georgia () - May 5, 2022 - Abstract #APA2022APA_842;
Introducing PP6M to the GA Medicaid program for managing adults with schizophrenia who are currently stabilized on PP1M or PP3M is projected to have a low impact on the state budget over 5 years. Modeling the impact of PP6M to the Medicaid budget of a state, like GA, can help policy makers with formulary decisions aimed at improving medication adherence and optimizing outcomes for beneficiaries with schizophrenia.

|||||||||| 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
Weight and Metabolic Changes in Patients with Schizophrenia with Paliperidone Palmitate 6 Monthly Versus Paliperidone Palmitate 3 Monthly Treatment: A Post-hoc Analysis (Spadolini Pavilion Upper Floor) - Mar 11, 2022 - Abstract #SIRS2022SIRS_100;
P3
From DB baseline to endpoint, the changes in BW, waist circumference and BMI were numerically higher in the PP3M group vs PP6M group. The mean (SD) increase in BW from MA baseline to DB endpoint were 0.10 (4.959) kg and 0.96 (5.103) kg for the PP6M and PP3M groups, respectively.

|||||||||| 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, 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).

|||||||||| paliperidone palmitate extended-release 6-month injection (R092670) / J&J
Clinical, sNDA: $JNJ Janssen Submits Paliperidone Palmitate 6-Month (PP6M) sNDA for Treatment of Schizophrenia in Adults (Twitter) - Nov 2, 2020

||||||||||  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,  Sponsor: Janssen Research & Development, LLC
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). Recruiting --> Active, not recruiting

|||||||||| Journal: Keeping up with the therapeutic advances in schizophrenia: a review of novel and emerging pharmacological entities. (Pubmed Central) - Aug 4, 2020
Most of these trial programs are still ongoing or have yielded mixed or even negative results. Thus, additional mechanisms of action and agents require study to improve schizophrenia outcomes for total/positive symptoms with reduced adverse effects, but also cognitive symptoms, negative symptoms, and treatment resistance, the areas of greatest need in schizophrenia currently.

||||||||||  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,  Sponsor: Janssen Research & Development, LLC
Thus, additional mechanisms of action and agents require study to improve schizophrenia outcomes for total/positive symptoms with reduced adverse effects, but also cognitive symptoms, negative symptoms, and treatment resistance, the areas of greatest need in schizophrenia currently. Active, not recruiting --> Completed | Trial completion date: Aug 2020 --> May 2020

||||||||||  Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Hafyera (paliperidone palmitate extended-release 6-month injection) / J&J
Enrollment open:  A Study of Paliperidone Palmitate 6-Month Formulation (clinicaltrials.gov) -  Sep 27, 2019
P3, N=160, Recruiting,  Sponsor: Janssen Research & Development, LLC
Active, not recruiting --> Completed | Trial completion date: Aug 2020 --> May 2020 Not yet recruiting --> Recruiting

||||||||||  Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Hafyera (paliperidone palmitate extended-release 6-month injection) / J&J
New P3 trial:  A Study of Paliperidone Palmitate 6-Month Formulation (clinicaltrials.gov) -  Aug 28, 2019
P3, N=160, Not yet recruiting,  Sponsor: Janssen Research & Development, LLC

||||||||||  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
Enrollment closed:  A Study of Paliperidone Palmitate 6-Month Formulation (clinicaltrials.gov) -  Apr 8, 2019
P3, N=840, Active, not recruiting,  Sponsor: Janssen Research & Development, LLC
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting

||||||||||  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
Enrollment open:  A Study of Paliperidone Palmitate 6-Month Formulation (clinicaltrials.gov) -  Dec 26, 2017
P3, N=765, Recruiting,  Sponsor: Janssen Research & Development, LLC
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting

||||||||||  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
New P3 trial:  A Study of Paliperidone Palmitate 6-Month Formulation (clinicaltrials.gov) -  Nov 17, 2017
P3, N=765, Not yet recruiting,  Sponsor: Janssen Research & Development, LLC

||||||||||  Invega Hafyera (paliperidone palmitate extended-release 6-month injection) / J&J
Trial completion:  PALMFlexS: Paliperidone Palmitate Flexible Dosing in Schizophrenia (clinicaltrials.gov) -  Feb 3, 2014
P3, N=1044, Completed,  Sponsor: Janssen-Cilag International NV
Not yet recruiting --> Recruiting Active, not recruiting --> Completed

||||||||||  Invega Hafyera (paliperidone palmitate extended-release 6-month injection) / J&J
Trial initiation date:  PALMFlexS: Paliperidone Palmitate Flexible Dosing in Schizophrenia (clinicaltrials.gov) -  Dec 27, 2012
P3, N=1044, Completed,  Sponsor: Janssen-Cilag International NV
Active, not recruiting --> Completed Initiation date: Aug 2010 --> Nov 2010



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