Iloperidone for schizophrenia: A review of the efficacy and safety profile for this newly commercialised second-generation antipsychotic

International Journal of Clinical Practice

Volumn 63, Issue 8, 2009, Pages 1237-1248

  Citrome, L ^a,b  

^a NEW YORK UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b NATHAN S KLINE INSTITUTE FOR PSYCHIATRIC RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER; FANAPT; FANAPTA; FIAPTA; HALOPERIDOL; ILOPERIDONE; PALIPERIDONE; PLACEBO; RISPERIDONE; UNCLASSIFIED DRUG; ZIPRASIDONE;

AGITATION; AKATHISIA; ANXIETY; CLINICAL TRIAL; DIZZINESS; DRUG EFFICACY; DRUG INDICATION; DRUG SAFETY; DRUG TOLERABILITY; DYSPEPSIA; DYSTONIA; EXTRAPYRAMIDAL SYMPTOM; FATIGUE; FLATULENCE; GENETIC MARKER; HEART RATE; HUMAN; NOSE CONGESTION; ORTHOSTATIC HYPOTENSION; PACKAGING; PHARMACOGENOMICS; POSITIVE AND NEGATIVE SYNDROME SCALE; PRIORITY JOURNAL; QT PROLONGATION; RECEPTOR AFFINITY; RESTLESSNESS; REVIEW; SCHIZOPHRENIA; SEDATION; SIDE EFFECT; SOMNOLENCE; TACHYCARDIA; TITRIMETRY; TREMOR; WEIGHT GAIN; XEROSTOMIA;

ANTIPSYCHOTIC AGENTS; CLINICAL TRIALS, PHASE III AS TOPIC; DRUG LABELING; HUMANS; ISOXAZOLES; PIPERIDINES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SAMPLE SIZE; SCHIZOPHRENIA; TREATMENT OUTCOME;

EID: 67749095284     PISSN: 13685031     EISSN: 17421241     Source Type: Journal    
DOI: 10.1111/j.1742-1241.2009.02142.x     Document Type: Review

References (31)

1. Vanda Pharmaceuticals. FDA Approves Vanda Pharmaceuticals' Fanapt™ for the Treatment of Schizophrenia. Press release, 6 May 2009. http://phx.corporate-ir.net/phoenix.zhtml?c=196233&p=RssLanding&cat= news&id=1285454 (accessed May 2009).
2. Vanda Pharmaceuticals. Vanda Pharmaceuticals Announces Receipt of not Approvable Letter from FDA for Iloperidone. Press release, 28 July 2008. http://phx.corporate-ir.net/phoenix.zhtml?c=196233&p=irol- newsArticle&ID=1179851&highlight = (accessed May 2009).
3. Vanda Pharmaceuticals. Fanapt (iloperidone) Tablets. http://www.fanapt. com/fanapt-pi-may09.pdf (accessed May 2009).
4. Strupczewski JT, Bordeau KJ, Chiang Y et al. 3-[[(Aryloxy)alkyl] piperidinyl]-1,2-benzisoxazoles as D2/5-HT2 antagonists with potential atypical antipsychotic activity: antipsychotic profile of iloperidone (HP 873). J Med Chem 1995 38 : 1119 31.
5. Corbett R, Hartman H, Kerman LL et al. Effects of atypical antipsychotic agents on social behavior in rodents. Pharmacol Biochem Behav 1993 45 : 9 17.
6. Potkin SG, Litman RE, Torres R, Wolfgang CD. Efficacy of iloperidone in the treatment of schizophrenia: initial phase 3 studies. J Clin Psychopharmacol 2008 28 (2 Suppl. 1 S4 11.
7. Weiden PJ, Cutler AJ, Polymeropoulos MH, Wolfgang CD. Safety profile of iloperidone: a pooled analysis of 6-week acute-phase pivotal trials. J Clin Psychopharmacol 2008 28 (2 Suppl. 1 S12 9.
8. Cutler AJ, Kalali AH, Weiden PJ, Hamilton J, Wolfgang CD. Four-week, double-blind, placebo- and ziprasidone-controlled trial of iloperidone in patients with acute exacerbations of schizophrenia. J Clin Psychopharmacol 2008 28 (2 Suppl. 1 S20 8.
9. Kane JM, Lauriello J, Laska E, Di Marino M, Wolfgang CD. Long-term efficacy and safety of iloperidone: results from 3 clinical trials for the treatment of schizophrenia. J Clin Psychopharmacol 2008 28 (2 Suppl. 1 S29 35.
10. Vanda Pharmaceuticals. Efficacy and Safety of Iloperidone Compared with Placebo and Active Control in Subjects with Acute Schizophrenia. ClinicalTrials.gov identifier NCT00254202. http://clinicaltrials.gov/ct2/show/ NCT00254202 (accessed May 2009).
11. Citrome L. Show me the evidence: using number needed to treat. South Med J 2007 100 : 881 4.
12. Citrome L. Compelling or irrelevant? Using number needed to treat can help decide Acta Psychiatr Scand 2008 117 : 412 9.
13. Citrome L Quantifying risk: the role of absolute and relative measures in interpreting risk of adverse reactions from product labels of antipsychotic medications. Curr Drug Saf 2009 4 (in press).
14. Kraemer HC, Kupfer DJ. Size of treatment effects and their importance to clinical research and practice. Biol Psychiatry 2006 59 : 990 6.
15. Corbett R, Griffiths L, Shipley JE et al. Iloperidone: preclinical profile and early clinical evaluation. CNS Drug Rev 1997 3 : 120 47.
16. Kalkman HO, Subramanian N, Hoyer D. Extended radioligand binding profile of iloperidone: a broad spectrum dopamine/serotonin/norepinephrine receptor antagonist for the management of psychotic disorders. Neuropsychopharmacology 2001 25 : 904 14.
17. Kalkman HO, Feuerbach D, Lötscher E, Schoeffter P. Functional characterization of the novel antipsychotic iloperidone at human D2, D3, alpha 2C, 5-HT6, and 5-HT1A receptors. Life Sci 2003 73 : 1151 9.
18. Kongsamut S, Roehr JE, Cai J et al. Iloperidone binding to human and rat dopamine and 5-HT receptors. Eur J Pharmacol 1996 317 : 417 23.
19. Szewczak MR, Corbett R, Rush DK et al. The pharmacological profile of iloperidone, a novel atypical antipsychotic agent. J Pharmacol Exp Ther 1995 274 : 1404 13.
20. Subramanian N, Kalkman HO. Receptor profile of P88-8991 and P95-12113, metabolites of the novel antipsychotic iloperidone. Prog Neuropsychopharmacol Biol Psychiatry 2002 26 : 553 60.
21. Shayegan DK, Stahl SM. Atypical antipsychotics: matching receptor profile to individual patient's clinical profile. CNS Spectr 2004 9 (Suppl. 11 6 14.
22. Sainati SM, Hubbard JW, Chi E, Grasing K, Brecher MB Safety, tolerability, and effect of food on the pharmacokinetics of iloperidone (HP 873), a potential atypical antipsychotic. J Clin Pharmacol 1995 35 : 713 20.
23. Pfizer. Geodon: US Package Insert for Geodon (ziprasidone HCl) and Geodon (ziprasidone mesylate) for Injection. LAB-0272-3.0; revised June 2008. http://www.pfizer.com/files/products/uspi-geodon.pdf (accessed May 2009).
24. Greenberg WM, Citrome L. Ziprasidone for schizophrenia and bipolar disorder: a review of the clinical trials. CNS Drug Rev 2007 13 : 137 77.
25. de Leon J. Pharmacogenomics: the promise of personalized medicine for CNS disorders. Neuropsychopharmacology 2009 34 : 159 72.
26. Volpi S, Heaton C, Mack K et al. Whole genome association study identifies polymorphisms associated with QT prolongation during iloperidone treatment of schizophrenia. Mol Psychiatry 2008 [Epub ahead of print]
27. Lavedan C, Licamele L, Volpi S et al. Association of the NPAS3 gene and five other loci with response to the antipsychotic iloperidone identified in a whole genome association study. Mol Psychiatry 2008 [Epub ahead of print]
28. Lavedan C, Volpi S, Polymeropoulos MH, Wolfgang CD. Effect of a ciliary neurotrophic factor polymorphism on schizophrenia symptom improvement in an iloperidone clinical trial. Pharmacogenomics 2008 9 : 289 301.
29. Hill CL, Phadke D, Boyce KM Four-week iloperidone depot injectable: safety and pharmacokinetic profile in patients with schizophrenia and schizoaffective disorder. Arlington, VA, USA: American Psychiatric Association 2008 Annual Meeting, Washington, DC, USA, May 3-8, 2008, New Research Abstracts, Poster NR4-022, 169 70.
30. Citrome L. Paliperidone: quo vadis? Int J Clin Pract 2007 61 : 653 62.
31. Albers LJ, Musenga A, Raggi MA. Iloperidone: a new benzisoxazole atypical antipsychotic drug. Is it novel enough to impact the crowded atypical antipsychotic market?. Expert Opin Investig Drugs 2008 17 : 61 75.