Olanzapine long-acting injection: A review of its use in the treatment of schizophrenia

Drugs

Volumn 70, Issue 17, 2010, Pages 2289-2313

  Frampton, James E ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

Adis Drug Evaluations; Controlled release drugs; Olanzapine, general; Schizophrenia

Indexed keywords

ATYPICAL ANTIPSYCHOTIC AGENT; LONG ACTING DRUG; OLANZAPINE; PLACEBO; RELPREVV; SEROTONIN RECEPTOR; UNCLASSIFIED DRUG; ZYPADHERA;

AGGRESSION; AGITATION; AKATHISIA; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANXIETY; AUDITORY HALLUCINATION; DIABETES MELLITUS; DRUG ABSORPTION; DRUG DISTRIBUTION; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG ELIMINATION; DRUG METABOLISM; DRUG RECEPTOR BINDING; DRUG TOLERABILITY; DYSLIPIDEMIA; EXTRAPYRAMIDAL SYNDROME; HEADACHE; HEALTH CARE FACILITY; HUMAN; HYPERPROLACTINEMIA; INJECTION SITE PAIN; INSOMNIA; MAINTENANCE THERAPY; ORTHOSTATIC HYPOTENSION; PARANOIA; PARANOID SCHIZOPHRENIA; PARKINSONISM; PHARMACODYNAMICS; PSYCHOSIS; REVIEW; RHINOPHARYNGITIS; RISK BENEFIT ANALYSIS; RISK MANAGEMENT; SCHIZOPHRENIA; SEDATION; SHORT COURSE THERAPY; SIDE EFFECT; SOMNOLENCE; SUICIDAL IDEATION; SUICIDE ATTEMPT; TREATMENT DURATION; WEIGHT GAIN;

ANTIPSYCHOTIC AGENTS; BENZODIAZEPINES; BLOOD GLUCOSE; CLINICAL TRIALS AS TOPIC; DELAYED-ACTION PREPARATIONS; HUMANS; INJECTIONS; LIPIDS; SCHIZOPHRENIA;

EID: 78549238253     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.2165/11204930-000000000-00000     Document Type: Review

References (77)

1. US Food and Drug Administration: Division of PsychiatricProducts. Psychopharmacologic Drugs Advisory Committee briefing document: Zyprexa® olanzapine pamoate (OP) depot (olanzapine long-acting injection) [online]. Available from URL: http://www.fda.gov/ohrms/dockets/ ac/08/briefing/2008- 4338b1-03-Lilly.pdf [Accessed 2010 Jul 13].
2. Gerstein PS. Schizophrenia [online]. Available from URL:http://emedicine. medscape.com/article/805988-overview [Accessed 2010 Aug 19].
3. Pani L. The need for individualised antipsychotic drug ther-apy in patients with schizophrenia. Eur Rev Med Pharmacol Sci 2009; 13 (6): 453-9.
4. Komossa K, Rummel-Kluge C, Hunger H, et al. Olanzapineversus other atypical antipsychotics for schizophrenia. Cochrane Database Syst Rev 2010 Mar 17; (3): CD006654.
5. van Os J, Kapur S. Schizophrenia. Lancet 2009 Aug 22;374 (9690): 635-45.
6. Hoarcek J, Bubenikova-Valesova V, Kopecek M, et al.Mechanism of action of atypical antipsychotic drugs and the neurobiology of schizophrenia. CNS Drugs 2006; 20 (5): 389-409.
7. Bishara D, Taylor D. Upcoming agents for the treatment ofschizophrenia: mechanism of action, efficacy and toler-ability. Drugs 2008; 68 (16): 2269-92.
8. Peritogiannis V, Tsouli S, Zafiris S, et al. Metabolic syn-drome and the use of antipsychotics. Ann Gen Psychiatry 2006; 5 Suppl. 1: S269.
9. Farah A. Atypicality of atypical antipsychotics. Prim CareCompanion J Clin Psychiatry 2005; 7: 268-74.
10. Ucok A, Gaebel W. Side effects of atypical antipsychotics:a brief overview. World Psychiatry 2008; 7: 58-62.
11. Rummel-Kluge C, Komossa K, Schwartz S, et al. Second-generation antipsychotic drugs and extrapyramidal side effects: a systematic review and meta-analysis of head-to-head comparisons. Schizophr Bull. Epub 2010 May 31.
12. San L, Casillas M, Cuidad A, et al. Olanzapine orally dis-integrating tablet: a review of efficacy and compliance. CNS Neurosci Ther 2008 Fall; 14 (3): 203-14.
13. Owen RT. Olanzapine: a review of rapid and long-actingparenteral formulations. Drugs Today (Barc) 2010 Mar; 46 (3): 173-81.
14. McCormack PL. Olanzapine: in adolescents with schizophreniaor bipolar I disorder. CNS Drugs 2010 May 1; 24 (5): 443-52.
15. Bhana N, Foster RH, Olney R, et al. Olanzapine: an up-dated review of its use in the management of schizophrenia. Drugs 2001; 61 (1): 111-61.
16. Zyprexa 2.5mg, 5mg, 7.5 mg, 10mg, 15mg, and 20mgcoatedtablets; Zyprexa Velotab 5mg, 10mg, 15mg, and 20mg or-odispersible tablets: summary of product characteristics. Basingstone, UK: Eli Lilly and Company, 2010 Jan 15.
17. Zyprexa (olanzapine) tablets for oral use; Zyprexa Zydis(olanzapine) tablet, orally disintegrating for oral use; Zy-prexa intramuscular (olanzapine) injection, powder, for solution for intramuscular use. US prescribing information. Indianapolis (IN): Eli Lilly and Company, 2010 May 27.
18. Wagstaff AJ, Easton J, Scott LJ. Intramuscular olanzapine:a review of its use in the management of acute agitation. CNS Drugs 2005; 19 (2): 147-64.
19. Zyprexa powder for solution for injection: summary ofproduct characteristics. Basingstone, UK: Eli Lilly and Company, 2010 Jan 19.
20. Zypadhera 210 mg, 300mg and 405 mg, powder and solventfor prolonged release suspension for injection: summary of product characteristics. Basingstone, UK: Eli Lilly and Company, 2010 Jan 19.
21. Zyprexa Relprevv (olanzapine) for extended release injectablesuspension: US prescribing information. Indianapolis (IN): Eli Lilly and Company, 2010 May 27.
22. Bymaster FP, Calligaro DO, Falcone JF, et al. Radio-receptor binding profile of the atypical antipsychotic olanzapine. Neuropsychopharmacology 1996; 14: 87-96.
23. Bymaster FP, Rasmussen K, Calligaro DO, et al. In vitro andin vivo biochemistry of olanzapine: a novel, atypical anti-psychotic drug. J Clin Psychiatry 1997; 58 Suppl. 10: 28-36.
24. Chiodo LA, Bunney BS. Typical and atypical neuroleptics:differential effects of chronic administration on the activity of A9 and A10 midbrain dopaminergic neurons. J Neurosci 1983; 3 (8): 1607-19.
25. Stockton ME, Rasmussen K. Electrophysiological effects ofolanzapine, a novel atypical antipsychotic, on A9 and A10 dopamine neurons. Neuropsychopharmacology 1996; 14: 97-104.
26. Meisenzahl EM, Dresel S, Frodl T, et al. D2 receptor occu-pancy under recommended and high doses of olanzapine: an iodine-123-iodobenzamide SPECT study. J Psycho-pharmacol 2000; 14 (4): 364-70.
27. Mamo D, Kapur S, Keshavan M, et al. D2 receptor occupancyof olanzapine pamoate depot using positron emission tomography: an open-label study in patients with schizophrenia. Neuropsychopharmacology 2008 Jan; 33 (2): 298-304.
28. Rummel-Kluge C, Komossa K, Schwartz S, et al. Head-to-head comparisons of metabolic side effects of second generation antipsychotics in the treatment of schizophrenia: a systematic review and meta-analysis. Schizophr Res 2010 Nov; 123 (2-3): 225-33.
29. Newcomer JW. Second-generation (atypical) antipsychoticsand metabolic effects: a comprehensive literature review. CNS Drugs 2005; 19 Suppl. 1: 1-93.
30. European Medicines Agency. Assessment Report for Zy-padhera [online]. Available from URL: http://www.ema. europa.eu/docs/en-GB/document-library/EPAR- Public- assessment-report/human/000890/WC500054428.pdf [Accessed 2010 Oct 20].
31. Kane JM, Detke HC, Naber D, et al. Olanzapine long-actinginjection: a 24-week, randomized, double-blind trial of maintenance treatment in patients with schizophrenia. Am J Psychiatry 2010 Feb; 167 (2): 181-9.
32. Kurtz D, Bergstrom R, McDonnell DP, et al. Pharmaco-kinetics (PK) of multiple doses of olanzapine long-acting injection (OLAI), an intramuscular (IM) depot formulation of olanzapine (OLZ), in stabilized patients with schizophrenia. Biol Psychiatry 2008; 63: 288S.
33. Lauriello J,Lambert T, AndersenS, etal.An 8-week, double-blind, randomized, placebo-controlled study of olanzapine long-acting injection in acutely ill patients with schizophrenia. J Clin Psychiatry 2008 May; 69 (5): 790-9.
34. Eli Lilly and Company. Olanzapine pamoate depot versusoral olanzapine on treatment outcomes in outpatients with schizophrenia [ClinicalTrials.gov identifier NCT00320489]. US National Institutes of Health, ClinicalTrials.gov [online]. Available from URL: http://clinicaltrials.gov [Accessed 2010 Jul 23].
35. Eli Lilly and Company. Open-label study of intramuscularolanzapine depot in outpatients with schizophrenia or schizoaffective disorder [ClinicalTrials.gov identifier NCT0088465]. US National Institutes of Health, Clinical Trials.gov [online]. Available from URL: http://clinicaltrials. gov [Accessed 2010 Jul 23].
36. Ascher-Svanum H, Peng X, Montgomery W, et al. Assessingthe infrequent oral supplementation of olanzapine long-acting injection in the treatment of schizophrenia. Eur Psychiatry. Epub 2010 Jul 9.
37. Detke HC, Zhao F, Garhyan P, et al. Dose correspondencebetween olanzapine long-acting injection and oral olanza-pine: recommendations for switching. Int Clin Psycho-pharmacol. Epub 2010 Oct 13.
38. McDonell D, Andersen S, Detke H, et al. Long-term open-label safety of olanzapine long-acting injection: 190-week interim results [abstract no. P-38-002 plus poster]. 9th World Congress of Biological Psychiatry; 2009 Jun 28-Jul 2; Paris.
39. Detke H, Zhao F, Andersen SW, et al. Comparison ofolanzapine long-acting injection switching methods: an 8-month analysis of patients with schizophrenia at risk of relapse [abstract no. NRI-023 plus poster]. 162nd Annual Meeting of the American Psychiatric Association; 2009 May 16-21; San Francisco (CA).
40. Detke H, McDonnell D, Andersen S, et al. Olanzapine long-acting injection in patients with schizophrenia at risk of relapse: 12-week switching data [abstract no. P.3.c.054]. Eur Neuropsychopharmacol 2008 Aug 30; 18 Suppl. 4: S435.
41. Detke HC, Weiden PJ, Lambert T, et al. Olanzapine long-acting injection vs oral olanzapine in schizophrenia outpatients: a 2-year, randomized, open-label study [abstract no. P.3.c.011]. Eur Neuropsychopharmacol 2010; 20 Suppl. 3: S464.
42. Godfrey JL, Detke HC, Montgomery WS, et al. Quality oflife and patient-reported outcomes: comparisons of individuals with schizophrenia treated with oral and long-acting injectable formulations of olanzapine [abstract no. PMH66]. 12th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research; 2009 Oct 24-27; Paris.
43. Beasley CMJ, Sutton VK, Hamilton SH, et al. A double-blind, randomized, placebo-controlled trial of olanzapinein the prevention of psychotic relapse. J Clin Psycho-pharmacol 2003 Dec; 23 (6): 582-94.
44. Center for Drug Evaluation and Research. Application num-ber: 22-173. Olanzapine pamoate depot [online]. Available from URL: http://www.accessdata. fda.gov/drugsatfda-docs/ nda/2009/022173s000MedR.pdf [Accessed 2010 Jul 29].
45. US Food and Drug Administration: PsychopharmacologicDrugs Advisory Committee Meeting Feb 6 2008. NDA22-173 olanzapine pamoate depot (OP depot) for the treatment of schizophrenia [online]. Available from URL: http:// www.fda.gov/ohrms/dockets/ac/08/slides/2008-4338s1-03-Lilly-Core-Backup.ppt#257, 1, [Accessed 2010 Aug 3].
46. Detke HC, McDonnell DP, Brunner E, et al. Post-injectiondelirium/sedation syndrome in patients with schizophrenia treated with olanzapine long-acting injection, I: analysis of cases. BMC Psychiatry 2010 Jun 10; 10 (43).
47. McDonnell DP, Detke HC, Bergstrom RF, et al. Post-injection delirium/sedation syndrome in patients with schizophrenia treated with olanzapine long-acting injection, II: investigations of mechanism. BMC Psychiatry 2010 Jun 10; 10 (45).
48. Gulliver A, McDonnell DP, Kryzhanovskaya LA, et al.Comparison of metabolic parameters during treatment for schizophrenia with olanzapine intramuscular long-acting injection versus olanzapine oral formulation [abstract no. P-02.80]. Int J Neuropsychopharmacol 2008; 11 Suppl. 1: 152. Plus poster presented at the 26th Collegium Internationale Neuro Psychopharmacologicum Congress; 2008 Jul 13-17; Munich.
49. Kane JM, Garcia-Ribera C. Clinical guideline recommend-ations for antipsychotic long-acting injections. Br J Psychiatry 2009; 195: s63-7.
50. Almond S, Knapp M, Francois C, et al. Relapse in schizo-phrenia: costs, clinical outcomes and quality of life. Br J Psychiatry 2004; 184: 346-51.
51. Welden PJ, Olfson M. Cost of relapse in schizophrenia.Schizophr Bull 1995; 21 (3): 419-29.
52. Oehl M, Hummer M, Fleischhacker WW. Compliance withantipsychotic treatment. Acta Psychiatr Scand Suppl 2000; 407: 83-6.
53. Patel MX, Taylor M, David AS. Antipsychotic long-actinginjections: mind the gap. Br J Psychiatry 2009; 195: s1-4.
54. Osterberg L. Adherence to medication. N Engl J Med 2005Aug 4; 353 (5): 487-97.
55. Masand PS, Roca M, Turner MS, et al. Partial adherence toantipsychotic medication impacts the course of illness in patients with schizophrenia: a review. Prim Care Companion J Clin Psychiatry 2009; 11 (4): 147-54.
56. Citrome L. Patient perspectives in the development and useof long-acting antipsychotics in schizophrenia: focus on olanzapine long-acting injection. Patient Prefer Adherence 2009; 3: 345-55.
57. Lieberman JA, Stroup TS, McEvoy JP, et al. Effectivenessof antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med 2005 Sep 22; 353 (12): 1209-33.
58. Masand PS, Narasimhan M. Improving adherence to anti-psychotic pharmacotherapy. Curr Clin Pharmacol 2006; 1: 47-56.
59. Lindenmayer JP. Long-acting injectable antipsychotics:focus on olanzapine pamoate. Neuropsychiatr Dis Treat 2010; 6: 261-7.
60. Busche CJ, Taylor M, Haukka J. Mortality in schizo-phrenia: a measurable clinical endpoint. J Psychopharma-col 2010, In press.
61. Raymont V. Suicide in schizophrenia: how can research in-fluence training and clinical practice. Psychiatric Bulletin 2001; 25: 46-50.
62. Altamura AC, Sassella F, Santini A, et al. Intramuscularpreparations of antipsychotics: uses and relevance in clinical practice. Drugs 2003; 63 (5): 493-512.
63. Haddad PM, Taylor M, Niaz OS. First-generation anti-psychotic long-acting injections v. oral antipsychotics in schizophrenia: systematic review of randomized controlled trials and observational studies. Br J Psychiatry 2009; 195: s20-8.
64. Fleischhacker WW. Second-generation antipsychotic long-acting injections: systematic review. Br J Psychiatry 2009; 195: s29-36.
65. Waddell L, Taylor M. Attitudes of patients and mentalhealth staff to antipsychotic long-acting injections: systematic review. Br J Psychiatry 2009; 195: s43-50.
66. Taylor D. Psychopharmacology and adverse effects ofantipsychotic long-acting injections: a review. Br J Psychiatry 2009; 195: s13-9.
67. Hoy SM, Scott LJ, Keating GM. Intramuscular paliper-idone palmitate. CNS Drugs 2010; 24 (3): 227-44.
68. Citrome L. Paliperidone palmitate: review of the effi-cacy, safety and cost of a new second-generation depot antipsychotic medication. Int J Clin Pract 2010 Jan; 64 (2): 216-39.
69. Harrison TS, Goa KL. Long-acting risperidone: a review ofits use in schizophrenia. CNS Drugs 2004; 18 (2): 113-32.
70. Jaeger M, Rossler W. Attitudes towards long-acting depotantipsychotics: a survey of patients, relatives and psychiatrists. Psychiatry Res 2010 Jan 30; 175 (1-2): 58-62.
71. Detke H, Zhao F, Carlson J, et al. Acute efficacy of olan-zapine long-acting injection, oral olanzapine, and haloperidol in patients with schizophrenia: a cross-study comparison. World J Biol Psych 2009; 10 Suppl. 1: 378.
72. Citrome L. Olanzapine pamoate: a stick in time? A review ofthe efficacy and safety profile of a new depot formulation of a second-generation antipsychotic. Int J Clin Pract 2009 Jan; 63 (1): 140-50.
73. Ascher-Syanum H, Montgomery W, Brnabic A, et al.Treatment completion rates of olanzapine and risperidone in long acting injectable formulations for the treatment of schizophrenia: a comparison of single arm open-lable studies [abstract no. P-02.119]. 26th Collegium Internationale Neuro Psychopharmacologicum Congress; 2008 Jul 13-17; Munich.
74. Akhras KS, Singh IGS. Comparison of treatment com-pletion rates for olanzapine pamoate and risperidone mi-crospheres. Int J Clin Pract 2009 Jun; 63 (6): 962-5.
75. Taylor DM. Olanzapine pamoate: blockbuster or dampsquib? Int J Clin Pract 2009 Apr; 63 (4): 540-1.
76. Ascher-Svanum H, Furiak NM, Klein RW, et al. Cost-effectiveness of olanzapine long-acting injection in the treatment of non-adherence in patients with schizophrenia in the United States [abstract no. PMH21]. Value Health 2009 May 16; 12 (3): A176.
77. Carroll SM, Jemiai N, Suter B, et al. Cost-effectivenessanalysis of olanzapine long-acting injection compared with risperidone long-acting injection in the treatment of schizophrenia in Norway [abstract no. PMH42]. 12th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research; 2009 Oct 24-27; Paris, A358