Lurasidone: The 2016 update on the pharmacology, efficacy and safety profile

Pharmacological Reports

Volumn 68, Issue 4, 2016, Pages 748-755

  Jaeschke, Rafał R ^a   Sowa Kućma, Magdalena ^b   Pańczyszyn Trzewik, Patrycja ^b   Misztak, Paulina ^b   Styczeń, Krzysztof ^a   Datka, Wojciech ^a  

^a JAGIELLONIAN UNIVERSITY MEDICAL COLLEGE   (Poland)

^b INSTITUTE OF PHARMACOLOGY   (Poland)

Author keywords

Atypical antipsychotics; Bipolar disorder; Lurasidone; Schizophrenia

Indexed keywords

ALBUMIN; CHLORPROMAZINE; CYTOCHROME P450 3A4; DIAZEPAM; DOPAMINE 2 RECEPTOR; ERYTHROMYCIN; ESTRADIOL; FLUCONAZOLE; HALOPERIDOL; KETOCONAZOLE; LITHIUM; LURASIDONE; NEUROLEPTIC AGENT; NORELGESTROMIN; OLANZAPINE; ORAL CONTRACEPTIVE AGENT; OROSOMUCOID; RIFAMPICIN; RISPERIDONE; RITONAVIR; SEROTONIN 2A RECEPTOR; SEROTONIN 7 RECEPTOR;

AKATHISIA; ANTIDEPRESSANT ACTIVITY; ANTIPSYCHOTIC ACTIVITY; AREA UNDER THE CURVE; BIPOLAR DEPRESSION; BIPOLAR DISORDER; CONCENTRATION AT STEADY-STATE; DRUG ABSORPTION; DRUG ACTIVITY; DRUG EFFICACY; DRUG METABOLISM; DRUG RECEPTOR BINDING; DRUG SAFETY; DRUG STRUCTURE; DRUG TOLERABILITY; DRUG TRANSFORMATION; EXTRAPYRAMIDAL SYMPTOM; HUMAN; HYPERPROLACTINEMIA; NONHUMAN; OBESITY; PARKINSONISM; PSYCHOPHARMACOLOGY; PSYCHOPHARMACOTHERAPY; RECOMMENDED DRUG DOSE; REVIEW; SCHIZOAFFECTIVE PSYCHOSIS; SCHIZOPHRENIA; SEDATION; SIDE EFFECT; TIME TO MAXIMUM PLASMA CONCENTRATION; ANIMAL; CHEMICALLY INDUCED; RADIOASSAY;

ANIMALS; ANTIPSYCHOTIC AGENTS; BIPOLAR DISORDER; HUMANS; HYPERPROLACTINEMIA; LURASIDONE HYDROCHLORIDE; RADIOLIGAND ASSAY; SCHIZOPHRENIA;

EID: 84975476243     PISSN: 22995684     EISSN: 22995684     Source Type: Journal    
DOI: 10.1016/j.pharep.2016.04.002     Document Type: Review

References (74)

1. American Psychiatric Association Desk reference to the diagnostic criteria from DSM-5 2013 American Psychiatric Association Arlington, VA
2. R. Liperoti, R. Bernabei, and G. Onder Managing antipsychotic medications in schizophrenia: comprehensive assessment and personalized care to improve clinical outcomes and reduce costs J Clin Psychiatry 76 9 2015 e1159 e1160
3. J.A. Salomon, T. Vos, D.R. Hogan, M. Gagnon, M. Naghavi, A. Mokdad, and et al. Common values in assessing health outcomes from disease and injury: disability weights measurement study for the Global Burden of Disease Study 2010 Lancet 380 9859 2012 2129 2143
4. H.A. Whiteford, L. Degenhardt, J. Rehm, A.J. Baxter, A.J. Ferrari, H.E. Erskine, and et al. Global burden of disease attributable to mental and substance use disorders: findings from the Global Burden of Disease Study 2010 Lancet 382 9904 2013 1575 1586
5. S.M. Stahl, D.A. Morrissette, L. Citrome, S.R. Saklad, M.A. Cummings, J.M. Meyer, and et al. "Meta-guidelines" for the management of patients with schizophrenia CNS Spectr 18 3 2013 150 162
6. L.N. Yatham, S.H. Kennedy, S.V. Parikh, A. Schaffer, S. Beaulieu, M. Alda, and et al. Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) collaborative update of CANMAT guidelines for the management of patients with bipolar disorder: update 2013 Bipolar Disord 15 1 2013 1 44
7. M. De Hert, W. Yu, J. Detraux, K. Sweers, R. van Winkel, and C.U. Correll Body weight and metabolic adverse effects of asenapine, iloperidone, lurasidone and paliperidone in the treatment of schizophrenia and bipolar disorder: a systematic review and exploratory meta-analysis CNS Drugs 26 9 2012 733 759
8. S. Leucht, A. Cipriani, L. Spineli, D. Mavridis, D. Orey, F. Richter, and et al. Comparative efficacy and tolerability of 15 antipsychotic drugs in schizophrenia: a multiple-treatments meta-analysis Lancet 382 9896 2013 951 962
9. A.G. Awad, and L.N. Voruganti The impact of newer atypical antipsychotics on patient-reported outcomes in schizophrenia CNS Drugs 27 8 2013 625 636
10. M.X. Patel, S. Collins, J. Hellier, G. Bhatia, and R.M. Murray The quality of reporting of phase II and III trials for new antipsychotics: a systematic review Psychol Med 45 3 2015 467 479
11. M. Jarema, A. Wichniak, D. Dudek, J. Samochowiec, P. Bienkowski, and J. Rybakowski Guidelines for the use of second-generation long-acting antipsychotics Psychiatr Pol 49 2 2015 225 241
12. A.M. Downing, B.J. Kinon, B.A. Millen, L. Zhang, L. Liu, M.A. Morozova, and et al. A double-blind, placebo-controlled comparator study of LY2140023 monohydrate in patients with schizophrenia BMC Psychiatry 14 2014 351
13. W. Zhang, M.I. Mitchell, M.P. Knadler, A. Long, J. Witcher, D. Walling, and et al. Effect of pomaglumetad methionil on the QT interval in subjects with schizophrenia Int J Clin Pharmacol Ther 53 6 2015 462 470
14. V.L. Stauffer, B.A. Millen, S. Andersen, B.J. Kinon, L. Lagrandeur, J.P. Lindenmayer, and et al. Pomaglumetad methionil: no significant difference as an adjunctive treatment for patients with prominent negative symptoms of schizophrenia compared to placebo Schizophr Res 150 2-3 2013 434 441
15. D. Umbricht, D. Alberati, M. Martin-Facklam, E. Borroni, E.A. Youssef, M. Ostland, and et al. Effect of bitopertin, a glycine reuptake inhibitor, on negative symptoms of schizophrenia: a randomized, double-blind, proof-of-concept study JAMA Psychiatry 71 6 2014 637 646
16. D. Bugarski-Kirola, A. Wang, D. Abi-Saab, and T. Blattler A phase II/III trial of bitopertin monotherapy compared with placebo in patients with an acute exacerbation of schizophrenia - results from the CandleLyte study Eur Neuropsychopharmacol 24 7 2014 1024 1036
17. G. Guyatt, B. Haynes, R. Jaeschke, M.O. Meade, M. Wilson, V. Montori, and et al. The philosophy of evidence-based medicine G. Guyatt, D. Rennie, M.O. Meade, D.J. Cook, Users' guides to the medical literature: a manual for evidence-based clinical practice 2008 McGraw-Hill 9 16
18. R. Jaeschke, M. Siwek, J. Brożek, and P. Brudkiewicz Randomized controlled trials in psychiatry Psychiatr Pol 46 1 2012 109 121
19. M.H. Murad, V.M. Montori, J.P. Ioannidis, R. Jaeschke, P.J. Devereaux, K. Prasad, and et al. How to read a systematic review and meta-analysis and apply the results to patient care: users' guides to the medical literature JAMA 312 2 2014 171 179
20. M.W. Lochmann van Bennekom, H.J. Gijsman, and F.G. Zitman Antipsychotic polypharmacy in psychotic disorders: a critical review of neurobiology, efficacy, tolerability and cost effectiveness J Psychopharmacol 27 4 2013 327 336
21. H.Y. Meltzer, and B.W. Massey The role of serotonin receptors in the action of atypical antipsychotic drugs Curr Opin Pharmacol 11 1 2011 59 67
22. T. Ishibashi, T. Horisawa, K. Tokuda, T. Ishiyama, M. Ogasa, R. Tagashira, and et al. Pharmacological profile of lurasidone, a novel antipsychotic agent with potent 5-hydroxytryptamine 7 (5-HT7) and 5-HT1A receptor activity J Pharmacol Exp Ther 334 1 2010 171 181
23. ® (lurasidone HCl) Tablets 2010 FDA
24. L. Citrome Lurasidone in schizophrenia: new information about dosage and place in therapy Adv Ther 29 10 2012 815 825
25. J.M. Meyer, A.D. Loebel, and E. Schweizer Lurasidone: a new drug in development for schizophrenia Expert Opin Investig Drugs 18 11 2009 1715 1726
26. A.V. Terry Jr., J.J. Buccafusco, and C. Wilson Cognitive dysfunction in neuropsychiatric disorders: selected serotonin receptor subtypes as therapeutic targets Behav Brain Res 195 1 2008 30 38
27. P. Bienkowski, D. Dudek, and J. Samochowiec Towards better non-selectivity: the role of 5-HT7 receptors in therapeutic efficacy of a second-generation antipsychotic - lurasidone Psychiatr Pol 49 2 2015 243 253
28. L. Citrome Lurasidone for schizophrenia: a brief review of a new second-generation antipsychotic Clin Schizophr Relat Psychoses 4 4 2011 251 257
29. S. Caccia, L. Pasina, and A. Nobili Critical appraisal of lurasidone in the management of schizophrenia Neuropsychiatr Dis Treat 8 2012 155 168
30. S. Preskorn, L. Ereshefsky, Y.Y. Chiu, N. Poola, and A. Loebel Effect of food on the pharmacokinetics of lurasidone: results of two randomized, open-label, crossover studies Hum Psychopharmacol 28 5 2013 495 505
31. L. Samalin, M. Garnier, and P.M. Llorca Clinical potential of lurasidone in the management of schizophrenia Ther Clin Risk Manag 7 2011 239 250
32. R. Franklin, S. Zorowitz, A.K. Corse, A.S. Widge, and T. Deckersbach Lurasidone for the treatment of bipolar depression: an evidence-based review Neuropsychiatr Dis Treat 11 2015 2143 2152
33. S. Madhusoodanan, U. Velama, J. Parmar, D. Goia, and R. Brenner A current review of cytochrome P450 interactions of psychotropic drugs Ann Clin Psychiatry 26 2 2014 120 138
34. Y.Y. Chiu, L. Ereshefsky, S.H. Preskorn, N. Poola, and A. Loebel Lurasidone drug-drug interaction studies: a comprehensive review Drug Metabol Drug Interact 29 3 2014 191 202
35. U.S. National Library of Medicine Toxicology Data Network.
36. M. Levine, and A.M. Ruha Overdose of atypical antipsychotics: clinical presentation, mechanisms of toxicity and management CNS Drugs 26 7 2012 601 611
37. H.Y. Meltzer, L. Rajagopal, M. Huang, Y. Oyamada, S. Kwon, and M. Horiguchi Translating the N-methyl-d-aspartate receptor antagonist model of schizophrenia to treatments for cognitive impairment in schizophrenia Int J Neuropsychopharmacol 16 2013 2181 2194
38. T. Ishiyama, K. Tokuda, T. Ishibashi, A. Ito, S. Toma, and Y. Ohno Lurasidone (SM-13496), a novel atypical antipsychotic drug, reverses MK-801-induced impairment of learning and memory in the rat passive-avoidance test Eur J Pharmacol 572 2-3 2007 160 170
39. T. Enomoto, T. Ishibashi, K. Tokuda, T. Ishiyama, S. Toma, and A. Ito Lurasidone reverses MK-801-induced impairment of learning and memory in the Morris water maze and radial-arm maze tests in rats Behav Brain Res 186 2 2008 197 207
40. T. Murai, T. Nakako, M. Ikejiri, T. Ishiyama, M. Taiji, and K. Ikeda Effects of lurasidone on executive function in common marmosets Behav Brain Res 246 2013 125 131
41. M. Horiguchi, K.E. Hannaway, A.E. Adelekun, K. Jayathilake, and H.Y. Meltzer Prevention of the phencyclidine-induced impairment in novel object recognition in female rats by co-administration of lurasidone or tandospirone, a 5-HT(1A) partial agonist Neuropsychopharmacology 37 10 2012 2175 2183
42. E.Y. Yuen, X. Li, J. Wei, M. Horiguchi, H.Y. Meltzer, and Z. Yan The novel antipsychotic drug lurasidone enhances N-methyl-d-aspartate receptor-mediated synaptic responses Mol Pharmacol 81 2 2012 113 119
43. T. Horisawa, T. Ishibashi, H. Nishikawa, T. Enomoto, S. Toma, T. Ishiyama, and et al. The effects of selective antagonists of serotonin 5-HT7 and 5-HT1A receptors on MK-801-induced impairment of learning and memory in the passive avoidance and Morris water maze tests in rats: mechanistic implications for the beneficial effects of the novel atypical antipsychotic lurasidone Behav Brain Res 220 2011 83 90
44. M. Horiguchi, M. Huang, and H.Y. Meltzer The role of 5-hydroxytryptamine 7 receptors in the phencyclidine-induced novel object recognition deficit in rats J Pharmacol Exp Ther 338 2 2011 605 614
45. M. Miyauchi, N.M. Neugebauer, Y. Oyamada, and H.Y. Meltzer Nicotinic receptors and lurasidone-mediated reversal of phencyclidine-induced deficit in novel object recognition Behav Brain Res 301 2016 204 212
46. A. Luoni, F. Macchi, M. Papp, R. Molteni, and M.A. Riva Lurasidone exerts antidepressant properties in the chronic mild stress model through the regulation of synaptic and neuroplastic mechanisms in the rat prefrontal cortex Int J Neuropsychopharmacol 18 4 2015 pyu061
47. F. Calabrese, E. Savino, M. Papp, R. Molteni, and M.A. Riva Chronic mild stress-induced alterations of clock gene expression in rat prefrontal cortex: modulatory effects of prolonged lurasidone treatment Pharmacol Res 104 2015 140 150
48. L.N. Cates, A.J. Roberts, S. Huitron-Resendiz, and P.B. Hedlund Effects of lurasidone in behavioral models of depression role of the 5-HT(7) receptor subtype Neuropharmacology 70 2013 211 217
49. A. Luoni, S. Hulsken, G. Cazzaniga, G. Racagni, J.R. Homberg, and M.A. Riva Behavioural and neuroplastic properties of chronic lurasidone treatment in serotonin transporter knockout rats Int J Neuropsychopharmacol 16 16 2013 1319 1330
50. T.L. Stan, V.C. Sousa, X. Zhang, M. Ono, and P. Svenningsson Lurasidone and fluoxetine reduce novelty-induced hypophagia and NMDA receptor subunit and PSD-95 expression in mouse brain Eur Neuropsychopharmacol 25 10 2015 1714 1722
51. F. Fumagalli, F. Calabrese, A. Luoni, F. Bolis, G. Racagni, and M.A. Riva Modulation of BDNF expression by repeated treatment with the novel antipsychotic lurasidone under basal condition and in response to acute stress Int J Neuropsychopharmacol 15 2 2012 235 246
52. A. Luoni, A. Berry, F. Calabrese, S. Capoccia, V. Bellisario, P. Gass, and et al. alterations in the prefrontal cortex of rats exposed to prenatal stress: preventive effect of lurasidone treatment during adolescence Eur Neuropsychopharmacol 24 6 2014 986 995
53. F. Calabrese, A. Luoni, G. Guidotti, G. Racagni, F. Fumagalli, and M.A. Riva Modulation of neuronal plasticity following chronic concomitant administration of the novel antipsychotic lurasidone with the mood stabilizer valproic acid Psychopharmacology 226 1 2013 101 112
54. J.P. McEvoy, L. Citrome, D. Hernandez, J. Cucchiaro, J. Hsu, A. Pikalov, and et al. Effectiveness of lurasidone in patients with schizophrenia or schizoaffective disorder switched from other antipsychotics: a randomized, 6-week, open-label study J Clin Psychiatry 74 2 2013 170 179
55. A. Loebel, J. Cucchiaro, K. Sarma, L. Xu, C. Hsu, A.H. Kalali, and et al. Efficacy and safety of lurasidone 80 mg/day and 160 mg/day in the treatment of schizophrenia: a randomized, double-blind, placebo- and active-controlled trial Schizophr Res 145 1-3 2013 101 109
56. A. Loebel, J. Cucchiaro, R. Silva, Y. Mao, J. Xu, A. Pikalov, and et al. Efficacy of lurasidone across five symptom dimensions of schizophrenia: pooled analysis of short-term, placebo-controlled studies Eur Psychiatry 30 1 2015 26 31
57. H.A. Nasrallah, J.B. Cucchiaro, Y. Mao, A.A. Pikalov, and A.D. Loebel Lurasidone for the treatment of depressive symptoms in schizophrenia: analysis of 4 pooled, 6-week, placebo-controlled studies CNS Spectr 20 2 2015 140 147
58. S. Leucht, M. Samara, S. Heres, M.X. Patel, S.W. Woods, and J.M. Davis Dose equivalents for second-generation antipsychotics: the minimum effective dose method Schizophr Bull 40 2 2014 314 326
59. C. Correll, J. Cucchiaro, R. Silva, J. Hsu, A. Pikalov, and A. Loebel Long-term safety and effectiveness of lurasidone in schizophrenia: results of a 22 month, open-label extension study Eur Psychiatry 29 2014 1
60. K. Styczeń, W. Datka, R. Jaeschke, K. Drozdowicz, M. Siwek, and D. Dudek The place of quetiapine extended release in the treatment of mental disorders Psychiatr Pol 49 1 2015 67 80
61. A. Loebel, J. Cucchiaro, J. Xu, K. Sarma, A. Pikalov, and J.M. Kane Effectiveness of lurasidone vs. quetiapine XR for relapse prevention in schizophrenia: a 12-month, double-blind, noninferiority study Schizophr Res 147 1 2013 95 102
62. S.M. Stahl, J. Cucchiaro, D. Simonelli, J. Hsu, A. Pikalov, and A. Loebel Effectiveness of lurasidone for patients with schizophrenia following 6 weeks of acute treatment with lurasidone, olanzapine, or placebo: a 6-month, open-label, extension study J Clin Psychiatry 74 5 2013 507 515
63. L. Citrome, P.J. Weiden, J.P. McEvoy, C.U. Correll, J. Cucchiaro, J. Hsu, and et al. Effectiveness of lurasidone in schizophrenia or schizoaffective patients switched from other antipsychotics: a 6-month, open-label, extension study CNS Spectr 19 4 2014 330 339
64. J.P. Higgins, D.G. Altman, P.C. Gotzsche, P. Juni, D. Moher, A.D. Oxman, and et al. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials BMJ 343 2011 d5928
65. L.J. Findlay, P. El-Mallakh, and R.S. El-Mallakh Management of bipolar I depression: clinical utility of lurasidone Ther Clin Risk Manag 11 2015 75 81
66. A. Loebel, J. Cucchiaro, R. Silva, H. Kroger, J. Hsu, K. Sarma, and et al. Lurasidone monotherapy in the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study Am J Psychiatry 171 2 2014 160 168
67. L. Citrome, T.A. Ketter, J. Cucchiaro, and A. Loebel Clinical assessment of lurasidone benefit and risk in the treatment of bipolar I depression using number needed to treat, number needed to harm, and likelihood to be helped or harmed J Affect Disord 155 2014 20 27
68. D.M. Taylor, V. Cornelius, L. Smith, and A.H. Young Comparative efficacy and acceptability of drug treatments for bipolar depression: a multiple-treatments meta-analysis Acta Psychiatr Scand 130 6 2014 452 469
69. A. Loebel, J. Cucchiaro, R. Silva, H. Kroger, K. Sarma, J. Xu, and et al. 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 171 2 2014 169 177
70. D. Popovic, A. Benabarre, J.M. Crespo, J.M. Goikolea, A. Gonzalez-Pinto, L. Gutierrez-Rojas, and et al. Risk factors for suicide in schizophrenia: systematic review and clinical recommendations Acta Psychiatr Scand 130 6 2014 418 426
71. A.D. Loebel, C.O. Siu, J.B. Cucchiaro, A.A. Pikalov, and P.D. Harvey Daytime sleepiness associated with lurasidone and quetiapine XR: results from a randomized double-blind, placebo-controlled trial in patients with schizophrenia CNS Spectr 19 2 2014 197 205
72. C.U. Correll, J. Detraux, J. De Lepeleire, and M. De Hert Effects of antipsychotics, antidepressants and mood stabilizers on risk for physical diseases in people with schizophrenia, depression and bipolar disorder World Psychiatry 14 2 2015 119 136
73. W.A. Ray, C.P. Chung, K.T. Murray, K. Hall, and C.M. Stein Atypical antipsychotic drugs and the risk of sudden cardiac death N Engl J Med 360 3 2009 225 235
74. S. Heres, J. Davis, K. Maino, E. Jetzinger, W. Kissling, and S. Leucht Why olanzapine beats risperidone, risperidone beats quetiapine, and quetiapine beats olanzapine: an exploratory analysis of head-to-head comparison studies of second-generation antipsychotics Am J Psychiatry 163 2 2006 185 194