Intramuscular paliperidone palmitate

CNS Drugs

Volumn 24, Issue 3, 2010, Pages 227-244

  Hoy, Sheridan M ^a   Scott, Lesley J ^a   Keating, Gillian M ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

AMIODARONE; ANTIARRHYTHMIC AGENT; ANTIINFECTIVE AGENT; CARBAMAZEPINE; CENTRAL MUSCLE RELAXANT; CHLORPROMAZINE; CYTOCHROME P450 2D6; CYTOCHROME P450 3A4; DOPAMINE RECEPTOR STIMULATING AGENT; GATIFLOXACIN; LEVODOPA; MOXIFLOXACIN; NEUROLEPTIC AGENT; PALIPERIDONE; PLACEBO; PROCAINAMIDE; QUINIDINE; RISPERIDONE; SOTALOL; SUSTENNA; THIORIDAZINE; UNCLASSIFIED DRUG; VALPROATE SEMISODIUM;

AGITATION; AKATHISIA; AMENORRHEA; AREA UNDER THE CURVE; BODY WEIGHT; CLINICAL GLOBAL IMPRESSION SCALE; CLINICAL TRIAL; COMPARTMENT MODEL; DISEASE SEVERITY; DISTRIBUTION VOLUME; DIZZINESS; DOSE RESPONSE; DRUG ABSORPTION; DRUG ANTAGONISM; DRUG CLEARANCE; DRUG EFFICACY; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG MECHANISM; DRUG METABOLISM; DRUG TOLERABILITY; DRUG WITHDRAWAL; EXTRAPYRAMIDAL SYMPTOM; HUMAN; HYPERPROLACTINEMIA; INJECTION SITE PAIN; INJECTION SITE REACTION; INJECTION SITE SWELLING; INSOMNIA; LIMB PAIN; MAINTENANCE THERAPY; MAXIMUM PLASMA CONCENTRATION; MENTAL DISEASE; MYALGIA; NONHUMAN; ORTHOSTATIC HYPOTENSION; PLASMA PROTEIN BINDING; POSITIVE AND NEGATIVE SYNDROME SCALE; PRIORITY JOURNAL; PROLACTIN BLOOD LEVEL; RECOMMENDED DRUG DOSE; RECURRENT DISEASE; REVIEW; RHINOPHARYNGITIS; SCHIZOPHRENIA; SEDATION; SIDE EFFECT; SOMNOLENCE; SUSTAINED DRUG RELEASE; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT OUTCOME;

ANTIPSYCHOTIC AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DRUG DELIVERY SYSTEMS; HUMANS; INJECTIONS, INTRAMUSCULAR; ISOXAZOLES; LONGITUDINAL STUDIES; PALMITATES; PSYCHIATRIC STATUS RATING SCALES; PYRIMIDINES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SCHIZOPHRENIA; SCHIZOPHRENIC PSYCHOLOGY; TREATMENT OUTCOME;

EID: 76949096476     PISSN: 11727047     EISSN: 11791934     Source Type: Journal    
DOI: 10.2165/11203810-000000000-00000     Document Type: Review

References (31)

1. Lieberman JA, Fenton WS. Delayed detection of psychosis: causes, consequences, and effect on public health. Am J Psychiatry 2000 Nov; 157 (11): 1727-1730
2. World Health Organization. Schizophrenia [online]. Available from URL: http://www.who.int/mental-health/management/schizophrenia/en/[Accessed 2009 Jul 20]
3. Ho B-C, Alicata D, Mola C, et al. Hippocampus volume and treatment delays in first-episode schizophrenia. Am J Psychiatry 2005 Aug; 162(8): 1527-1529
4. Keith SJ, Pani L, Nick B, et al. Practical application of pharma-cotherapy with long-acting risperidone for patients with schizophrenia. Psychiatr Serv 2004 Sep; 55 (9): 997-1005
5. Hough D, Lindenmayer J-P, Gopal S, et al. Safety and tol-erability of deltoid and gluteal injections of paliperidone palmitate in schizophrenia. Prog Neuropsychopharmacol Biol Psychiatry 2009; 33: 1022-1031
6. Nasrallah HA. The case for long-acting antipsychotic agents in the post-CATIE era. Acta Psychiatr Scand 2007 Apr; 115 (4): 260-267
7. Fleischhacker WW, Gopal S, Samtani MN, et al. Optimi-zation of the dosing strategy for the long-acting injectable antipsychotic paliperidone palmitate: results of two randomized double-blind studies and population pharmacokinetic simulations [poster]. American Psychiatric Association Annual Meeting; 2009 May 16-21; San Francisco (CA)
8. Samtani MN, Vermeulen A, Stuyckens K. Population pharmacokinetics of intramuscular paliperidone palmitate in patients with schizophrenia: a novel once-monthly, long-acting formulation of an atypical antipsychotic. Clin Pharmacokinet 2009; 48 (9): 585-600
9. Ortho-McNeil-Janssen Pharmaceuticals Inc. FDA approves Invega® Sustenna™ for the acute and maintenance treatment of schizophrenia [online]. Available from URL: http://www.janssen.com/janssen/news-release.html? item=073109-1 [Accessed 2009 Aug 5]
10. Ortho-McNeil-Janssen Pharmaceuticals Inc. Invega® Sus-tenna™ (paliperidone palmitate) extended-release injectible suspension: prescribing information [online]. Available from URL: http://www.invegasustenna.com/ invegasustenna/shar ed/pi/invegasustenna.pdf [Accessed 2009 Aug 4]
11. Gopal S, Vijapurkar U, Lim P, et al. Long-term efficacy, safety, and tolerability of paliperidone palmitate in patients with schizophrenia [abstract no. NR1-031 plus poster]. Annual Meeting of the College of Psychiatric and Neurologic Pharmacists; 2009 Apr 19-22; Jacksonville (FL)
12. Yang LP, Plosker GL. Paliperidone extended release. CNS Drugs 2007; 21 (5): 417-25; discussion 426-427
13. Karlsson P, Dencker E, Nyberg S, et al. Pharmacokinetics and dopamine D2 and serotonin 5-HT2A receptor occupancy of paliperidone in healthy subjects [abstract no. P.1.053]. Eur Neuropsychopharmacol 2005 Oct; 15 Suppl. 3: S386. Plus poster presented at the 18th European Congress of Neuropsychopharmacology; 2005 Oct 22-26; Amsterdam
14. Remington G, Mamo D, Labelle A, et al. A PET study evaluating dopamine D2 receptor occupancy for long-acting injectable risperidone. Am J Psychiatry 2006 Mar; 163 (3): 396-401
15. Kapur S, Zipursky R, Jones C, et al. Relationship between dopamine D2 occupancy, clinical response, and side effects: a double-blind PET study of first-episode schizophrenia. Am J Psychiatry 2000 Apr; 157 (4): 514-520
16. Kapur S, Zipursky RB, Remington G. Clinical and theoret-ical implications of 5-HT2 and D2 receptor occupancy of clozapine, risperidone, and olanzapine in schizophrenia. Am J Psychiatry 1999 Feb; 156 (2): 286-293
17. Pandina G, Lindenmayer J, Lull J, et al. A randomized, double-blind, placebo-controlled, dose-response study to assess efficacy and safety of paliperidone palmitate in adult subjects with schizophrenia [abstract plus poster]. 12th International Congress on Schizophrenia Research; 2009 Mar 28-Apr 1; San Diego (CA)
18. Cleton A, Rossenu S, Hough D, et al. Assessment of the dose proportionality of paliperidone palmitate 25, 50, 100 and 150mg eq., a new long-acting injectable antipsychotic following administration in the deltoid or gluteal muscles [abstract no. PI-74]. Clin Pharmacol Ther 2008 Mar; 83 Suppl. 1: S31. Plus poster presented at the American Society for Clinical Pharmacology and Therapeutics; 2008 Apr 2-5; Orlando (FL)
19. Cleton A, Rossenu S, Hough D, et al. Evaluation of the pharmacokinetic profile of gluteal versus deltoid intramuscular injections of paliperidone palmitate 100 mg equivalent in patients with schizophrenia [abstract no. PI-75]. Clin Pharmacol Ther 2008 Mar; 83 Suppl. 1: S31. Plus poster presented at the American Society for Clinical Pharmacology and Therapeutics; 2008 Apr 2-5; Orlando (FL)
20. Kern-Sliwa J, Samtani MN, Haskins JT, et al. Initiation dosing of deltoid intramuscular paliperidone palmitate in schizophrenia: pharmacokinetic rationale based on modeling and simulation [abstract no. NR1-046 plus poster]. Annual Meeting of the College of Psychiatric and Neurologic Pharmacists; 2009 Apr 19-22; Jackonville (FL)
21. Haskins JT, Samtani MN, Alphs L, et al. Maintenance dosing of once-monthly (4-weekly) paliperidone palmitate in schizophrenia: pharmacokinetic rationale based on population simulations [abstract no. NR1-036 plus poster]. Annual Meeting of the College of Psychiatric and Neurologic Pharmacists; 2009 Apr 19-22; Jacksonville (FL)
22. Samtani MN, Gopal S, Kern-Sliwa J, et al. Management of missed paliperidone palmitate doses based on pharmaco-kinetic modeling and simulation [poster]. 49th Annual New Clinical Drug Evaluation Unit Meeting; 2009 Jun 29-Jul 2; Hollywood (FL)
23. Nasrallah HA, Gopal S, Quiroz JA, et al. Efficacy and safety of three doses of paliperidone palmitate, an investigational long-acting injectable antipsychotic, in schizophrenia [abstract NR4-036 plus poster]. 161st Annual Meeting of the American Psychiatric Association; 2008 May 3-8; Washington, DC
24. Kramer M, Litman R, Hough D, et al. Paliperidone palmi-tate, a potential long-acting treatment for patients with schizophrenia: results of a randomized, double-blind, placebo-controlled efficacy and safety study. Int J Neuro-psychopharmacol. Epub 2009 Nov 27
25. Johnson & Johnson Pharmaceutical Research & Develop-ment L.L.C. A study to evaluate the effectiveness and safety of 3 doses of paliperidone palmitate in treating subjects with schizophrenia [ClinicalTrials.gov identifier NCT00210548]. US National Institutes of Health, Clin-icalTrials.gov [online]. Available from URL: http://clinicaltrials.gov [Accessed 2009 Oct 8]
26. Johnson & Johnson Pharmaceutical Research & Development L.L.C. A study to evaluate the effectiveness and safety of 3 doses of paliperidone palmitate in treating subjects with schizophrenia [online]. Available from URL: http://down load.veritasmedicine.com/PDF/CR002353-CSR.pdf [Accessed 2009 Oct 8]
27. 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. Epub 2009 Dec 1
28. Johnson & Johnson Pharmaceutical Research & Develop-ment L.L.C. Efficacy and safety of a long acting anti-psychotic versus placebo in patients with schizophrenia [ClinicalTrials.gov identifier NCT00101634]. US National Institutes of Health, ClinicalTrials.gov [online]. Available from URL: http://www.clinicaltrials.gov [Accessed 2009 Dec 15]
29. Johnson & Johnson Pharmaceutical Research & Development L.L.C. Efficacy and safety of a long acting anti-psychotic versus placebo in patients with schizophrenia [online]. Available from URL: http://download. veritasmedicine.com/PDF/CR003562-CSR.pdf [Accessed 2009 Dec 15]
30. Alphs L, Bossie C, Kern-Sliwa J, et al. Paliperidone palmi-tate: clinical response in subjects with schizophrenia with recent vs. longer-term duration of illness [abstract no. NR6-027 plus poster]. 162nd Annual Meeting of the American Psychiatric Association; 2009 May 16-21; San Francisco (CA) Data on file, Ortho-McNeil-Janssen Pharmaceuticals Inc., 2009 American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 4th ed. Washington, DC: American Psychiatric Association, 1994
31. American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 4th ed., text revision. Washington, DC: American Psychiatric Association, 2000