The current data on the 3-month paliperidone palmitate formulation for the treatment of schizophrenia

References

• Owen MJ, Sawa A, Mortensen PB. Schizophrenia. Lancet. 2016 Jul 2;388(10039):86–97.
   PubMedGoogle Scholar
• Velligan DI, Weiden PJ, Sajatovic M, et al. Assessment of adherence problems in patients with serious and persistent mental illness: recommendations from the expert consensus guidelines. J Psychiatr Pract. 2010;16(1):34–45.
   PubMed Web of Science ®Google Scholar
• Lieberman JA, Stroup TS, McEvoy JP, et al. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med. 2005;353(12):1209–1223.
   PubMed Web of Science ®Google Scholar
• Kahn RS, Fleischhacker WW, Boter H, et al. Effectiveness of antipsychotic drugs in first-episode schizophrenia and schizophreniform disorder: an open randomised clinical trial. Lancet. 2008;371(9618):1085–1097.
   PubMed Web of Science ®Google Scholar
• Kishimoto T, Agarwal V, Kishi T, et al. Relapse prevention in schizophrenia: a systematic review and meta-analysis of second-generation antipsychotics versus first-generation antipsychotics. Mol Psychiatry. 2013;18(1):53–66.
   PubMed Web of Science ®Google Scholar
• Kane JM, Kishimoto T, Correll CU. Non-adherence to medication in patients with psychotic disorders: epidemiology, contributing factors and management strategies. World Psychiatry. 2013;12(3):216–226.
   PubMed Web of Science ®Google Scholar
• Taipale H, Mittendorfer-Rutz E, Alexanderson K, et al. Antipsychotics and mortality in a nationwide cohort of 29,823 patients with schizophrenia. Schizophr Res. 2018 Jul;197:274–280.
   Web of Science ®Google Scholar
• Parellada E, Bioque M. Barriers to the use of long-acting injectable antipsychotics in the management of schizophrenia. CNS Drugs. 2016;30(8):689–701.
   PubMed Web of Science ®Google Scholar
• Carpenter WT Jr., Buchanan RW. Expanding therapy with long-acting antipsychotic medication in patients with schizophrenia. JAMA Psychiatry. 2015;72(8):745–746.
   PubMed Web of Science ®Google Scholar
• Halfdanarson O, Zoega H, Aagaard L, et al. International trends in antipsychotic use: a study in 16 countries, 2005-2014. Eur Neuropsychopharmacol. 2017;27(10):1064–1076.
   PubMed Web of Science ®Google Scholar
• Haddad PM, Brain C, Scott J. Nonadherence with antipsychotic medication in schizophrenia: challenges and management strategies. Patient Relat Outcome Meas. 2014;5:43–62.
   PubMedGoogle Scholar
• Davis JM, Matalon L, Watanabe MD, et al. Depot antipsychotic drugs. Place in Therapy. Drugs. 1994;47(5):741–773.
   PubMed Web of Science ®Google Scholar
• Kishimoto T, Robenzadeh A, Leucht C, et al. Long-acting injectable vs oral antipsychotics for relapse prevention in schizophrenia: a meta-analysis of randomized trials. Schizophr Bull. 2014;40(1):192–213.
   PubMed Web of Science ®Google Scholar
• Ostuzzi G, Papola D, Gastaldon C, et al. New EMA report on paliperidone 3-month injections: taking clinical and policy decisions without an adequate evidence base. Epidemiol Psychiatr Sci. 2017;26(3):231–233.
   PubMed Web of Science ®Google Scholar
• Suzuki T. A further consideration on long-acting injectable versus oral antipsychotics in the treatment of schizophrenia: a narrative review and critical appraisal. Expert Opin Drug Deliv. 2016;13(2):253–264.
   PubMed Web of Science ®Google Scholar
• Bernardo M, Bioque M. Three-month paliperidone palmitate - a new treatment option for schizophrenia. Expert Rev Clin Pharmacol. 2016;9(7):899–904.
   PubMed Web of Science ®Google Scholar
• Kishimoto T, Nitta M, Borenstein M, et al. Long-acting injectable versus oral antipsychotics in schizophrenia: a systematic review and meta-analysis of mirror-image studies. J Clin Psychiatry. 2013;74(10):957–965.
   PubMed Web of Science ®Google Scholar
• Nussbaum M, Stroup TS. Paliperidone palmitate for schizophrenia. Cochrane Database Syst Rev. 2012. DOI:10.1002/14651858.CD008296.pub2
   PubMed Web of Science ®Google Scholar
• Janssen. Invega Sustenna (paliperidone palmitate) extended-release injectable suspension prescribing information. Orth-McNeil-Janssen Pharmaceuticals, Inc; 2009.
   Google Scholar
• Schoretsanitis G, Spina E, Hiemke C, et al. A systematic review and combined analysis of therapeutic drug monitoring studies for oral paliperidone. Expert Rev Clin Pharmacol. 2018;11(6):625–639.
   PubMed Web of Science ®Google Scholar
• Yasui-Furukori N, Kubo K, Ishioka M, et al. Interaction between paliperidone and carbamazepine. Ther Drug Monit. 2013;35(5):649–652.
   PubMed Web of Science ®Google Scholar
• Spina E, Crupi R. Safety and efficacy of paliperidone extended-release in acute and maintenance treatment of schizophrenia. J Cent Nerv Syst Dis. 2011;3:27–41.
   PubMedGoogle Scholar
• Food and Drug Administration. FDA webpage. 2016 [cited 2018 Aug 21]. Available from: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails
   Google Scholar
• Parellada E, Bioque M, Serrano M, et al. An open-treatment six-week study of the clinical effectiveness of paliperidone palmitate in schizophrenia: data from acute units in Spain (SHADOW study). Int J Psychiatry Clin Pract. 2018 Sep;22(3):191–199.
   PubMed Web of Science ®Google Scholar
• Nussbaum AM, Stroup TS. Paliperidone palmitate for schizophrenia. Schizophr Bull. 2012;38(6):1124–1127.
   PubMed Web of Science ®Google Scholar
• Gonzalez-Rodriguez A, Catalan R, Penades R, et al. Profile of paliperidone palmitate once-monthly long-acting injectable in the management of schizophrenia: long-term safety, efficacy, and patient acceptability - a review. Patient Prefer Adherence. 2015;9:695–706.
   PubMedGoogle Scholar
• Hough D, Gopal S, Vijapurkar U, et al. Paliperidone palmitate maintenance treatment in delaying the time-to-relapse in patients with schizophrenia: a randomized, double-blind, placebo-controlled study. Schizophr Res. 2010;116(2–3):107–117.
   PubMed Web of Science ®Google Scholar
• Pandina G, Lane R, Gopal S, et al. A double-blind study of paliperidone palmitate and risperidone long-acting injectable in adults with schizophrenia. Prog Neuropsychopharmacol Biol Psychiatry. 2011;35(1):218–226.
   PubMed Web of Science ®Google Scholar
• Nasrallah HA, Gopal S, Gassmann-Mayer C, et al. A controlled, evidence-based trial of paliperidone palmitate, a long-acting injectable antipsychotic, in schizophrenia. Neuropsychopharmacology. 2010;35(10):2072–2082.
   PubMed Web of Science ®Google Scholar
• Bossie CA, Fu DJ, Sliwa JK, et al. Tolerability of initiation doses of once-monthly paliperidone palmitate in patients with recently diagnosed schizophrenia in an acute treatment trial. Ther Adv Psychopharmacol. 2011;1(4):111–124.
   PubMedGoogle Scholar
• Bossie CA, Sliwa JK, Ma YW, et al. Onset of efficacy and tolerability following the initiation dosing of long-acting paliperidone palmitate: post-hoc analyses of a randomized, double-blind clinical trial. BMC Psychiatry. 2011;11:79.
   PubMed Web of Science ®Google Scholar
• Alphs L, Bossie CA, Sliwa JK, et al. Onset of efficacy with acute long-acting injectable paliperidone palmitate treatment in markedly to severely ill patients with schizophrenia: post hoc analysis of a randomized, double-blind clinical trial. Ann Gen Psychiatry. 2011;10(1):12.
   PubMed Web of Science ®Google Scholar
• Li H, Rui Q, Ning X, et al. A comparative study of paliperidone palmitate and risperidone long-acting injectable therapy in schizophrenia. Prog Neuropsychopharmacol Biol Psychiatry. 2011;35(4):1002–1008.
   PubMed Web of Science ®Google Scholar
• Fleischhacker WW, Gopal S, Lane R, et al. A randomized trial of paliperidone palmitate and risperidone long-acting injectable in schizophrenia. Int J Neuropsychopharmacol. 2012;15(1):107–118.
   PubMed Web of Science ®Google Scholar
• Schreiner A, Bergmans P, Cherubin P, et al. A prospective flexible-dose study of paliperidone palmitate in nonacute but symptomatic patients with schizophrenia previously unsuccessfully treated with oral antipsychotic agents. Clin Ther. 2014;36(10):1372–1388 e1.
   PubMed Web of Science ®Google Scholar
• Alphs L, Benson C, Cheshire-Kinney K, et al. Real-world outcomes of paliperidone palmitate compared to daily oral antipsychotic therapy in schizophrenia: a randomized, open-label, review board-blinded 15-month study. J Clin Psychiatry. 2015;76(5):554–561.
   PubMed Web of Science ®Google Scholar
• Hargarter L, Cherubin P, Bergmans P, et al. Intramuscular long-acting paliperidone palmitate in acute patients with schizophrenia unsuccessfully treated with oral antipsychotics. Prog Neuropsychopharmacol Biol Psychiatry. 2015;58:1–7.
   PubMed Web of Science ®Google Scholar
• Zhang F, Si T, Chiou CF, et al. Efficacy, safety, and impact on hospitalizations of paliperidone palmitate in recent-onset schizophrenia. Neuropsychiatr Dis Treat. 2015;11:657–668.
   PubMed Web of Science ®Google Scholar
• Emsley R, Parellada E, Bioque M, et al. Real-world data on paliperidone palmitate for the treatment of schizophrenia and other psychotic disorders: a systematic review of randomized and nonrandomized studies. Int Clin Psychopharmacol. 2017;33(1):15–33.
   Web of Science ®Google Scholar
• European Medicines Agency. European public assessment report. 2018 [cited 2018 Aug 21]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004066/human_med_001829.jsp&mid=WC0b01ac058001d124
   Google Scholar
• Gopal S, Vermeulen A, Nandy P, et al. Practical guidance for dosing and switching from paliperidone palmitate 1 monthly to 3 monthly formulation in schizophrenia. Curr Med Res Opin. 2017;31(11):2043–2054.
   Web of Science ®Google Scholar
• Magnusson MO, Samtani MN, Plan EL, et al. Dosing and switching strategies for paliperidone palmitate 3-month formulation in patients with schizophrenia based on population pharmacokinetic modeling and simulation, and clinical trial data. CNS Drugs. 2017;31(4):273–288.
   PubMed Web of Science ®Google Scholar
• Samtani MN, Nandy P, Ravenstijn P, et al. Prospective dose selection and acceleration of paliperidone palmitate 3-month formulation development using a pharmacometric bridging strategy. Br J Clin Pharmacol. 2016;82(5):1364–1370.
   PubMed Web of Science ®Google Scholar
• Ravenstijn P, Remmerie B, Savitz A, et al. Pharmacokinetics, safety, and tolerability of paliperidone palmitate 3-month formulation in patients with schizophrenia: a phase-1, single-dose, randomized, open-label study. J Clin Pharmacol. 2016;56(3):330–339.
   PubMed Web of Science ®Google Scholar
• Berwaerts J, Liu Y, Gopal S, et al. Efficacy and Safety of the 3-month formulation of paliperidone palmitate vs placebo for relapse prevention of schizophrenia: a randomized clinical trial. JAMA Psychiatry. 2015 Aug;72(8):830–839.
   PubMed Web of Science ®Google Scholar
• Savitz AJ, Xu H, Gopal S, et al. Efficacy and safety of paliperidone palmitate 3-month formulation for patients with schizophrenia: a randomized, multicenter, double-blind, noninferiority study. Int J Neuropsychopharmacol. 2016 Jul 5;19(7). pii: pyw018. doi: 10.1093/ijnp/pyw018.
   PubMed Web of Science ®Google Scholar
• Joshi K, Lafeuille M-H, Brown B, et al. Baseline characteristics and treatment patterns of patients with schizophrenia initiated on once-every-three-months paliperidone palmitate in a real-world setting. Curr Med Res Opin. 2017;33(10):1763–1772.
   PubMed Web of Science ®Google Scholar
• Kerbusch-Herben V, Cleton A, Berwaerts J, et al. Effect of carbamazepine on the pharmacokinetics of paliperidone extended-release tablets at steady-state. Clin Pharmacol Drug Dev. 2014;3(5):371–377.
   PubMed Web of Science ®Google Scholar
• Daghistani N, Rey JA. Invega Trinza: the first four-times-a-year, long-acting injectable antipsychotic agent. Pharmacy and Therapeutics. 2016;41(4):222–227.
   Google Scholar
• Savitz AJ, Xu H, Gopal S, et al. Paliperidone palmitate 3-month treatment results in symptomatic remission in patients with schizophrenia: a randomized, multicenter, double-blind, and noninferiority study. Int Clin Psychopharmacol. 2017;32(6):329–336.
   PubMed Web of Science ®Google Scholar
• Weiden PJ, Kim E, Bermak J, et al. Does half-life matter after antipsychotic discontinuation? A relapse comparison in schizophrenia with 3 different formulations of paliperidone. J Clin Psychiatry. 2017;78(7):e813–e820.
   PubMed Web of Science ®Google Scholar
• Mathews M, Gopal S, Singha A, et al. A comparison of schizophrenia relapse rates of 3 paliperidone formulations, once-daily, once-monthly and once every-3-month: post hoc analysis from 3 randomized controlled trials (Poster), in Schizophrenia International Research Society Meeitng; Firenze, Italy; 2018.
   Google Scholar
• Mathews M, Gopal S, Singha A, et al. Comparison of paliperidone palmitate 3-month and paliperidone palmitate 1-month formulation for negative symptoms in schizophrenia: a phase 3 non-inferiority study (Poster), in Schizophrenia International Research Society Meeting; Firenze, Italy; 2018.
   Google Scholar
• Mauri MC, Reggiori A, Paletta S, et al. Paliperidone for the treatment of schizophrenia and schizoaffective disorders - a drug safety evaluation. Expert Opin Drug Saf. 2017;16(3):365–379.
   PubMed Web of Science ®Google Scholar
• Katz EG, Hauber B, Gopal S, et al. Physician and patient benefit-risk preferences from two randomized long-acting injectable antipsychotic trials. Patient Prefer Adherence. 2016;10:2127–2139.
   PubMed Web of Science ®Google Scholar
• Gopal S, Xu H, McQuarrie K, et al. Caregiver burden in schizophrenia following paliperidone palmitate long acting injectables treatment: pooled analysis of two double-blind randomized phase three studies. NPJ Schizophrenia. 2017;3:23.
   PubMed Web of Science ®Google Scholar
• Einarson TR, Bereza BG, Garcia Llinares I, et al. Cost-effectiveness of 3-month paliperidone treatment for chronic schizophrenia in Spain. J Med Econ. 2017;20(10):1039–1047.
   PubMed Web of Science ®Google Scholar
• Einarson TR, Bereza BG, Tedouri F, et al. Cost-effectiveness of 3-month paliperidone therapy for chronic schizophrenia in the Netherlands. J Med Econ. 2017;20(11):1187–1199.
   PubMed Web of Science ®Google Scholar
• Stahl SM. Long-acting injectable antipsychotics: shall the last be first? CNS Spectr. 2014;19(1):3–5.
   PubMed Web of Science ®Google Scholar
• Tiihonen J, Haukka J, Taylor M, et al. A nationwide cohort study of oral and depot antipsychotics after first hospitalization for schizophrenia. Am J Psychiatry. 2011;168(6):603–609.
   PubMed Web of Science ®Google Scholar
• Malla A, Tibbo P, Chue P, et al. Long-acting injectable antipsychotics: recommendations for clinicians. Can J Psychiatry. 2013;58(5Suppl 1):30S–5S.
   PubMedGoogle Scholar
• Manchanda R, Chue P, Malla A, et al. Long-acting injectable antipsychotics: evidence of effectiveness and use. Can J Psychiatry. 2013;58(5Suppl 1):5S–13S.
   PubMedGoogle Scholar
• Azorin JM. Guidelines on long-acting injectable atypical antipsychotics for first-episode schizophrenia. Encephale. 2013;39(Suppl 2):S121–S123.
   PubMed Web of Science ®Google Scholar
• Subotnik KL, Casaus LR, Ventura J, et al. Long-acting injectable risperidone for relapse prevention and control of breakthrough symptoms after a recent first episode of schizophrenia: a randomized clinical trial. JAMA Psychiatry. 2015;72(8):822–829.
   PubMed Web of Science ®Google Scholar
• Leza JC, Garcia-Bueno B, Bioque M, et al. Inflammation in schizophrenia: a question of balance. Neurosci Biobehav Rev. 2015;55:612–626.
   PubMed Web of Science ®Google Scholar
• Fusar-Poli P, McGorry PD, Kane JM. Improving outcomes of first-episode psychosis: an overview. World Psychiatry. 2017;16(3):251–265.
   PubMed Web of Science ®Google Scholar
• Patel M, Haddad P, Chaudhry I, et al. Psychiatrists’ use, knowledge and attitudes to first- and second-generation antipsychotic long-acting injections: comparisons over 5 years. J Psychopharmacol. 2010;24(10):1473–1482.
   PubMed Web of Science ®Google Scholar
• Naber D, Hansen K, Forray C, et al. Qualify: a randomized head-to-head study of aripiprazole once-monthly and paliperidone palmitate in the treatment of schizophrenia. Schizophr Res. 2015;168(1–2):498–504.
   PubMed Web of Science ®Google Scholar
• Druais S, Doutriaux A, Cognet M, et al. Cost effectiveness of paliperidone long-acting injectable versus other antipsychotics for the maintenance treatment of schizophrenia in France. Pharmacoeconomics. 2016;34:363–391.
   PubMed Web of Science ®Google Scholar
• Mahlich JR, Nishi M, Saito Y. Modeling the budget impact of long-acting injectable paliperidone palmitate in the treatment of schizophrenia in Japan. CEOR. 2015;7:267–272.
   Google Scholar
• Zeidler J, Mahlich J, Greiner W, et al. Cost effectiveness of paliperidone palmitate for the treatment of schizophrenia in Germany. Appl Health Econ Health Policy. 2013;11(5):509–521.
   PubMedGoogle Scholar
• Einarson TR, Maia-Lopes S, Goswami P, et al. Economic analysis of paliperidone long-acting injectable for chronic schizophrenia in Portugal. J Med Econ. 2016Sep;19(9):913–921.
   Web of Science ®Google Scholar