Novel atypical antipsychotics: Metabolism and therapeutic drug monitoring (TDM)

Current Drug Metabolism

Volumn 16, Issue 2, 2015, Pages 141-151

  Mandrioli, Roberto ^a   Protti, Michele ^a   Mercolini, Laura ^a  

^a UNIVERSITY OF BOLOGNA   (Italy)

Author keywords

Asenapine; Atypical antipsychotics; Iloperidone; Lurasidone; Metabolism; Therapeutic drug monitoring

Indexed keywords

ASENAPINE; ILOPERIDONE; LURASIDONE; FUSED HETEROCYCLIC RINGS; ISOXAZOLE DERIVATIVE; NEUROLEPTIC AGENT; PIPERIDINE DERIVATIVE;

ARTICLE; DRUG APPROVAL; DRUG METABOLISM; DRUG MONITORING; HUMAN; NONHUMAN; PERSONALIZED MEDICINE; QUALITY OF LIFE; SCHIZOPHRENIA; ANIMAL; DRUG DESIGN; FOOD AND DRUG ADMINISTRATION; PROCEDURES; UNITED STATES;

ANIMALS; ANTIPSYCHOTIC AGENTS; DRUG APPROVAL; DRUG DESIGN; DRUG MONITORING; HETEROCYCLIC COMPOUNDS WITH 4 OR MORE RINGS; HUMANS; ISOXAZOLES; LURASIDONE HYDROCHLORIDE; PIPERIDINES; SCHIZOPHRENIA; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84938816310     PISSN: 13892002     EISSN: 18755453     Source Type: Journal    
DOI: 10.2174/1389200216666150602145005     Document Type: Article

References (84)

1. Hellewell, J.S.E.; Gerlach, J.E.S. Opportunities and challenges presented by the new generation antipsychotics. Int. J. Psychiatr. Clin. Pract., 2000, 4, S53-S61.
2. Chue, P.; Lalonde, J.K. Addressing the unmet needs of patients with persistent negative symptoms of schizophrenia: emerging pharmacological treatment options. Neuropsychiatr. Dis. Treat., 2014, 10, 777-789.
3. Carpenter, W.T.; Davis, J.M. Another view of the history of antipsychotic drug discovery and development. Mol. Psychiatr., 2012, 17, 1168-1173.
4. Sauriol, L.; Laporta, M.; Edwardes, M.D.; Deslandes, M.; Ricard, N.; Suissa, S. Meta-analysis comparing newer antipsychotic drugs for the treatment of schizophrenia: evaluating the indirect approach. Clin. Ther., 2001, 23, 942-956.
5. Citrome, L. A systematic review of meta-analyses of the efficacy of oral atypical antipsychotics for the treatment of adult patients with schizophrenia. Exp. Opin. Pharmacother., 2012, 13, 1545-73.
6. Manschreck, T.C.; Boshes, R.A. The CATIE schizophrenia trial: results, impact, controversy. Harv. Rev. Psychiat., 2007, 15, 245-258.
7. Bates, D.W.; Gawande, A.A. Improving safety with information technology. N. Engl. J. Med., 2003, 348, 2526-2534.
8. Best-Shaw, L.; Gudbrandsen, M.; Nagar, J.; Rose, D.; David, A.S.; Patel, M.X. Psychiatrists' perspectives on antipsychotic dose and the role of plasma concentration therapeutic drug monitoring. Ther. Drug. Monit., 2014, 36, 486-493.
9. Hiemke, C.; Baumann, P.; Bergemann, N.; Conca, A.; Dietmaier, O.; Egberts, K.; Fric, M.; Gerlach, M.; Greiner, C.; Gründer, G.; Haen, E.; Havemann-Reinecke, U.; Jaquenoud Sirot, E.; Kirchherr, H.; Laux, G.; Lutz, U.C.; Messer, T.; Müller, M.J.; Pfuhlmann, B.; Rambeck, B.; Riederer, P.; Schoppek, B.; Stingl, J.; Uhr, M.; Ulrich, S.; Waschgler, R.; Zernig, G. AGNP Consensus Guidelines for Therapeutic Drug Monitoring in Psychiatry: Update 2011. Pharmacopsychiatry, 2011, 44, 195-235.
10. Patteet, L.; Morrens, M.; Maudens, K.E.; Niemegeers, P.; Sabbe, B.; Neels, H.; Therapeutic Drug Monitoring of Common Antipsychotics. Ther. Drug. Monit., 2012, 34, 629-651.
11. Raggi, M.A.; Mandrioli, R.; Sabbioni, C.; Pucci, V. Atypical antipsychotics: pharmacokinetics, therapeutic drug monitoring and pharmacological interactions. Curr. Med. Chem., 2004, 11, 279-296.
12. Mandrioli, R; Mercolini, L.; Saracino, M.A.; Raggi, M.A. Selective serotonin reuptake inhibitors (SSRIs): therapeutic drug monitoring and pharmacological interactions. Curr. Med. Chem., 2012, 19, 1846-1863.
13. Müller, M.J.; Dragicevic, A.; Fric, M.; Gaertner, I.; Grasmäder, K.; Härtter, S.; Hermann, E.; Kuss, H.J.; Laux, G.; Oehl, W.; Rao, M.L.; Rollmann, N.; Weigmann, H.; Weber-Labonte, M.; Hiemke, C. Therapeutic drug monitoring of tricyclic antidepressants: how does it work under clinical conditions? Pharmacopsychiatry, 2003, 36, 98-104.
14. Perry, P.J. Therapeutic drug monitoring of antipsychotics. Psychopharmacol. Bull., 2001, 35, 19-29.
15. Hiemke, C.; Dragicevic, A.; Gründer, G.; Hätter, S.; Sachse, J.; Vernaleken I.; Müller, M.J. Therapeutic monitoring of new antipsychotic drugs. Ther. Drug. Monit., 2004, 26, 156-60.
16. Merli, R.; Haefele, E. Therapeutic drug monitoring use in clinical practice of a mental health service. Pharmacopsychiatry, 2011, 21, A12.
17. AGNP, AG. Therapeutisches Drug Monitoring. (http://www. agnp.de/AGNP-Homepage-Dateien/Arbeitsgruppen/ag-tdm.htm) (Accessed December 10, 2014).
18. Baumann, P.; Hiemke, C.; Ulrich, S.; Eckermann, G.; Gaertner, I.; Gerlach, M.; Kuss, H.J.; Laux, G.; Müller-Oerlinghausen, B.; Rao, M.L.; Riederer, P.; Zernig, G. Arbeitsge-meinschaft fur neuropsychopharmakologie und pharmakopsychiatrie. The AGNPTDM expert group consensus guidelines: therapeutic drug monitoring in psychiatry. Pharmacopsychiatry, 2004, 37, 243-265.
19. Mercolini, L.; Grillo, M.; Bartoletti, C.; Boncompagni, G.; Raggi, M.A. Simultaneous analysis of classical neuroleptics, atypical antipsychotics and their metabolites in human plasma. Anal. Bioanal. Chem., 2007, 388, 235-243.
20. Caccia, S.; Pasina, L.; Nobili, A. Critical appraisal of lurasidone in the management of schizophrenia. Neuropsychiatr. Dis. Treat., 2012, 8, 155-168.
21. Huang, M.; Horiguchi, M.; Felix, A.R.; Meltzer, H.Y. 5-HT1A and 5-HT7 receptors contribute to lurasidone-induced dopamine efflux. Neuroreport., 2012, 23, 436-40.
22. European Medicines Agency, Procedure No. EMEA/H/C/002713/0000, Latuda assessment report. (http://www.ema.europa. eu/docs/en-GB/document-library/EPAR---Public-assessment- report/human/002713/WC500164684.pdf) (Accessed December 9, 2014).
23. ClinicalTrials.gov, Trial identifier NCT01620060, Lurasidone Pediatric Pharmacokinetics Study. (https://clinicaltrials.gov/ct2/ show/results/NCT01620060?sect=X01256#all) (Accessed December 9, 2014).
24. Therapeutic Goods Administration, Australian public assessment report for lurasidone hydrochloride. (http://www.tga.gov.au/file/ 5938/download) (Accessed December 11, 2014).
25. Center for Drug Evaluation and Research, Application number 200603, Pharmacology Review(s). (http://www.accessdata. fda.gov/drugsatfda-docs/nda/2010/200603Orig1s000PharmR.pdf) (Accessed December 11, 2014).
26. Woo, Y.S.; Wang, H.R.; Bahk, W.M. Lurasidone as a potential therapy for bipolar disorder. Neuropsychiatr. Dis. Treat., 2013, 9, 1521-1529.
27. Citrome, L. Lurasidone for schizophrenia: a review of the efficacy and safety profile for this newly approved second-generation antipsychotic. Int. J. Clin. Pract., 2011, 65, 189-210.
28. Sunovion Pharmaceutical Inc., Latuda (lurasidone HCl) Prescribing Information. (http://www.latuda.com/LatudaPrescribingInformation. pdf) (Accessed December 11, 2014).
29. Meyer, J.M.; Loebel, A.D.; Schweizer, E. Lurasidone: a new drug in development for schizophrenia. Expert. Opin. Investig. Drugs, 2009, 18, 1715-1726.
30. Kennedy, W.K.; Jann, M.W.; Kutscher, E.C. Clinically significant drug interactions with atypical antipsychotics. CNS Drugs, 2013, 27, 1021-1048.
31. Ozdemir, V.; Kalow, W.; Tang, B.K.; Paterson, A.D.; Walker, S.E.; Endrenyi, L.; Kashuba, A.D. Evaluation of the genetic component of variability in CYP3A4 activity: a repeated drug administration method. Pharmacogenetics, 2000, 10, 373-388.
32. Ravyn, D.; Ravyn, V.; Lowney, R.; Nasrallah, H.A.; CYP450 Pharmacogenetic treatment strategies for antipsychotics: A review of the evidence. Schizophr. Res., 2013, 149, 1-14.
33. Westlind-Johnsson, A.; Hermann, R.; Huennemeyer, A.; Hauns, B.; Lahu, G.; Nassr, N.; Zech, K.; Ingelman-Sundberg, M.; von Richter, O.; Identification and characterization of CYP3A4∗20, a novel rare CYP3A4 allele without functional activity. Clin. Pharmacol. Ther., 2006, 79, 339-349.
34. McGraw, J.; Waller, D.; Cytochrome P450 variations in different ethnic populations. Expert Opin. Drug Metab. Toxicol., 2012, 8, 371-382.
35. Elens, L.; Bouamar, R.; Hesselink, D.A.; Haufroid, V.; van Gelder, T.; van Schaik, R.H.; The new CYP3A4 intron 6 C N T polymorphism (CYP3A4∗22) is associated with an increased risk of delayed graft function and worse renal function in cyclosporine- treated kidney transplant patients. Pharmacogenet. Genomics, 2012, 22, 373-380.
36. Lamba, J.K.; Lin, Y.S.; Schuetz, E.G.; Thummel, K.E. Genetic contribution to variable human CYP3A-mediated metabolism. Adv. Drug Deliv. Rev., 2012, 54, 1271-1294.
37. Loebel, A.; Cucchiaro, J.; Silva, R.; Kroger, H.; Sarma, K.; Xu, J.; Calabrese, J.R. Lurasidone as adjunctive therapy with lithium or valproate for the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am. J. Psychiatry, 2014, 171, 169-177.
38. Chiu, Y.Y.; Ereshefsky, L.; Preskorn, S.H.; Poola, N.; Loebel, A. Lurasidone drug-drug interaction studies: a comprehensive review. Drug Metab. Drug Interact., 2014, 29, 191-202.
39. Potkin, S.G.; Keator, D.B.; Kesler-West, M.L.; Nguyen, D.D.; van Erp, T.G.M.; Mukherjee, J.; Shah, N.; Preda, A. D2 receptor occupancy following lurasidone treatment in patients with schizo phrenia or schizoaffective disorder. CNS Spectrums, 2014, 19, 176-181.
40. Nordström, A.L.; Farde, L.; Wiesel, F.A.; Forslund, K.; Pauli, S.; Halldin, C.; Uppfeldt, G. Central D2-dopamine receptor occupancy in relation to antipsychotic drug effects: a double-blind PET study of schizophrenic patients. Biol. Psychiat., 1993, 33, 227-235.
41. Patteet, L.; Maudens, K.E.; Sabbe, B.; Morrens, M.; De Doncker, M.; Neels, H. High throughput identification and quantification of 16 antipsychotics and 8 major metabolites in serum using ultrahigh performance liquid chromatography-tandem mass spectrometry. Clin. Chim. Acta, 2014, 429, 51-58.
42. Patteet, L.; Maudens, K.E.; Stove, C.P.; Lambert, W.E.; Morrens, M.; Sabbe, B.; Neels, H. The use of dried blood spots for quantification of 15 antipsychotics and 7 metabolites with ultra-high performance liquid chromatography - tandem mass spectrometry. Drug. Test. Anal., 2014 (in Press).
43. Mercolini, L.; Mandrioli, R.; Protti, M.; Conca, A.; Albers, L.J.; Raggi, M.A. Dried Blood Spot (DBS) testing: a novel approach for the therapeutic drug monitoring of patients treated with ziprasidone. Bioanalysis, 2014, 6, 1487-1495.
44. Chae, Y.J.; Koo, T.S.; Lee, K.R. A sensitive and selective LC-MS method for the determination of lurasidone in rat plasma, bile, and urine. Chromatographia, 2012, 75, 1117-1128.
45. Koo, T.S.; Kim, S.J.; Lee, J.; Ha, D.J.; Baek, M.; Moon, H.; Quantification of lurasidone, an atypical antipsychotic drug, in rat plasma with high-performance liquid chromatography with tandem mass spectrometry. Biomed. Chromatogr., 2011, 25, 1389-1394.
46. Minassian, A; Young, J.W. Evaluation of the clinical efficacy of asenapine in schizophrenia. Expert Opin. Pharmacol., 2010, 11, 2107-2115.
47. Food and Drug Administration, NDA 22-117 approval letter. (http://www.accessdata.fda.gov/drugsatfda-docs/appletter/2009/0 22117s000ltr.pdf) (Accessed December 11, 2014).
48. Food and Drug Administration, NDA 22117/S-003/S-004 approval letter. (http://www.accessdata.fda.gov/drugsatfda-docs/ appletter/2010/022117s003s004ltr.pdf) (Accessed December 11, 2014).
49. European Medicines Agency, EPAR summary for the public: Sycrest asenapine. (http://www.ema.europa.eu/ema/index.jsp? curl=pages/medicines/human/medicines/001177/human-med-00 1379.jsp&mid=WC0b01ac058001d124)(Accessed December 11, 2014).
50. Shahid, M.; Walker, G.B.; Zorn, S.H.; Wong, E.H.; Asenapine: a novel psychopharmacologic agent with a unique human receptor signature. J. Psychopharmacol., 2009, 23, 65-73.
51. Ghanbari, R.; El Mansari, M.; Shahid, M.; Blier, P. Electrophysiological characterization of the effects of asenapine at 5- HT1A, 5-HT2A, a2-adrenergic and D2 receptors in the rat brain. Eur. Neuropsychopharmacol., 2009, 19, 177-187.
52. Food and Drug Administration, Saphris prescribing information. (http://www.accessdata.fda.gov/drugsatfda-docs/label/2014/022 117s014s015s016lbl.pdf) (Accessed December 12, 2014).
53. Balaraman, R.; Gandhi, H. Asenapine, a new sublingual atypical antipsychotic. J. Pharmacol. Pharmacother., 2010, 1, 60-61.
54. Weber, J.; McCormack, P. L. Asenapine. CNS Drugs, 2009, 23, 781-792.
55. Van de Wetering-Krebbers, S.F.M.; Jacobs, P.L.; Kemperman, G.J.; Spaans, E.; Peeters, P.A.M.; Delbressine, L.P.C.; Van Iersel, M.L.P.S. Metabolism and excretion of asenapine in healthy male subjects. Drug. Metab. Dispos., 2011, 39, 580-590.
56. Center for Drug Evaluation and Research, Application number 22-117, Pharmacology review(s). (http://www.accessdata. fda.gov/drugsatfda-docs/nda/2009/022117s000-PharmR.pdf) (Accessed December 13, 2014).
57. de Boer, T.; Meulman, E.; Meijering, H.; Wieling, J.; Dogterom, P.; Lass, H. Quantification of asenapine and three metabolites in human plasma using liquid chromatography - tandem mass spectrometry with automated solid-phase extraction: application to a phase I clinical trial with asenapine in healthy male subjects. Biomed. Chromatogr., 2012, 26, 156-165.
58. de Boer, T.; Meulman, E.; Meijering, H.; Wieling, J.; Dogterom, P.; Lass, H. Development and validation of automated SPEHPLC- MS/MS methods for the quantification of asenapine, a new antipsychotic agent, and its two major metabolites in human urine. Biomed. Chromatogr., 2012, 26, 1461-1463.
59. H. Lundbeck A/S, PrSaphris® Product Monograph. (http://www.lundbeck.com/upload/ca/en/files/pdf/pm/SAPHRIS.pd f) (Accessed December 13, 2014).
60. Conca, A. Asenapine: a systematic review on the main topics of clinical practice. J. Psychopathol., 2013, 19, 245-261.
61. Center for Drug Evaluation and Research, Application number 22-117, Clinical pharmacology and biopharmaceutics review(s) (http://www.accessdata.fda.gov/drugsatfda-docs/nda/2009/0221 17s000-ClinPharmR-P1.pdf) (Accessed December 13, 2014).
62. Flockhart, D.A. Drug interactions: cytochrome P450 drug interaction table. Indiana University School of Medicine (2007). (http://medicine.iupui.edu/clinpharm/ddis/clinical-table/) (Accessed December 13, 2014).
63. Therapeutic Goods Administration, Australian public assessment report for asenapine. (http://www.tga.gov.au/auspar/ausparasenapine) (Accessed December 13, 2014).
64. Ansermot, N; Brawand-Amey, M.; Kottelat, A.; Eap, C.B. Fast quantification of ten psychotropic drugs and metabolites in human plasma by ultra-high performance liquid chromatography tandem mass spectrometry for therapeutic drug monitoring. J. Chrom. A, 2013, 1292, 160-172.
65. Miller, C.; Pleitez, O.; Anderson, D.; Mertens-Maxham, D. Wade, N. Asenapine (Saphris): GC-MS Method Validation and the Postmortem Distribution of a New Atypical Antipsychotic Medication. J. Anal. Toxicol., 2013, 37, 559-564.
66. Food and Drug Administration, NDA 022192 approval letter. (http://www.accessdata.fda.gov/drugsatfda-docs/appletter/2009/0 22192s000ltr.pdf) (Last accessed 10 December 2014).
67. European Medicines Agency, Vanda Pharmaceuticals Ltd withdraws its marketing-authorisation application for Fanaptum (iloperidone). (http://www.ema.europa.eu/ema/index.jsp?curl=pages/ medicines/human/medicines/002371/wapp/Initial-authorisation/ human-wapp-000162.jsp&mid=WC0b01ac058001d128) (Accessed December 13, 2014).
68. Kongsamut, S.; Roehr, J.; Cai J, Hartman, H.B.; Weissensee, P.; Kerman, L.L.; Tang, L.; Sandrasagra, A. Iloperidone binding to human and rat dopamine and 5-HT receptors. Eur. J. Pharmacol., 1996, 317, 417-423.
69. Kalkman, H.O.; 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, 904-914.
70. Kalkman, H.O.; Feuerbach, D.; Loetscher, E.; Schoeffter, P. Functional characterization of the novel antipsychotic Iloperidone at human D2, D3, -2C, 5-HT6 and 5-HT1A receptors. Life Sci., 2003, 73, 1151-1159.
71. Center for Drug Evaluation and Research, Iloperidone drug details. (http://www.accessdata.fda.gov/scripts/cder/drugsatfda/ index.cfm?fuseaction=Search.DrugDetails) (Acces sed December 10, 2014).
72. Novartis Inc., Fanapt prescribing information. (http://www. pharma.us.novartis.com/product/pi/pdf/fanapt.pdf) (Accessed December 10, 2014).
73. Jia, M.; Li, J.; He, X.; Liu, M.; Zhou, Y.; Fan, Y.; Li, W. Simultaneous determination of iloperidone and its two active metabolites in human plasma by liquid chromatography-tandem mass spectrometry: Application to a pharmacokinetic study. J. Chromatogr. B, 2013, 928, 52-57.
74. European Medicines Agency, Procedure No. EMEA/H/C/002371/ 0000 assessment report. (http://www.ema.europa.eu/docs/en- GB/document-library/Application-withdrawal-assessment-rep ort/h uman/002371/WC500143487.pdf) (Accessed December 10, 2014).
75. Mutlib, A.E.; Klein, J.T. Application of liquid chromatography/ mass spectrometry in accelerating the identification of human liver cytochrome P450 isoforms involved in the metabolism of Iloperidone. J. Pharmacol. Exp. Ther., 1998, 286, 1285-1293.
76. Subramanian, N.; Kalkman, H.O. Receptor profile of P88-8991 and P95-12113, metabolites of the novel antipsychotic Iloperidone. Progr. Neuro-Psychoph., 2002, 26, 553-560.
77. Mutlib, A.E.; Strupczewski, J.T.; Chesson, S.M. Application of hyphenated LC/NMR and LC/MS techniques in rapid identifica tion of in vitro and in vivo metabolites of Iloperidone. Drug Metab. Dispos., 1995, 23, 951-964.
78. Sheehan, J.J.; Sliwa, J.K.; Amatniek, J.C.; Grinspan, A.; Canuso, C. M. Atypical Antipsychotic Metabolism and Excretion. Curr. Drug Metab., 2010, 11, 516-525.
79. Baroldi, P.; Wolfgang, C. A Pharmacokinetic (PK)- Pharmacodinamic (PD) relationship exist for efficacy of Iloperidone: a novel investigation atypical antipsychotic agent. American Psychiatric Association, 160th annual meeting: San Diego (USA), 2007 (NR507).
80. Mutlib, A.E.; Strupczewski, J.T. Picogram determination of iloperidone in human plasma by solid-phase extraction and by highperformance liquid chromatography-selected-ion monitoring electrospray mass spectrometry. J. Chromatogr. B, 1995, 669, 237-246.
81. Parekh, J.M.; Sanyal, M.; Yadav, M.; Shrivastav, P.S. Stableisotope dilution LC-MS/MS assay for determination of iloperidone and its two major metabolites, P 88 and P 95, in human plasma: Application to a bioequivalence study. Bioanalysis, 2013, 5, 669-686.
82. Caccia, S.; Invernizzi, R.W.; Nobili, A.; Pasina, L.A new generation of antipsychotics: pharmacology and clinical utility of cariprazine in schizophrenia. Ther. Clin. Risk. Manag., 2013, 9, 319-328.
83. Köster, L.S.; Carbon, M.; Correll, C.U. Emerging drugs for schizophrenia: an update. Expert Opin. Emerg. Drugs, 2014, 19, 511-531.
84. Bengtsson, F. Therapeutic Drug Monitoring of Psychotropic Drugs: TDM "Nouveau". Ther. Drug Monit., 2004, 26, 145-151.