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Drug Safety Evaluations

Asenapine review, part II: clinical efficacy, safety and tolerability

, MD MPH
Pages 803-830 | Published online: 03 May 2014

Bibliography

  • American Psychiatric Association. Diagnostic and statistical manual of mental disorders DSM-IV-TR, Fourth edition (Text Revision). American Psychiatric Publishing, Inc., Arlington, Virginia; 2000
  • Volavka J, Citrome L. Oral antipsychotics for the treatment of schizophrenia: heterogeneity in efficacy and tolerability should drive decision-making. Expert Opin Pharmacother 2009;10(12):1917-28
  • Citrome L, Ketter TA, Cucchiaro J, Loebel A. 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 2014;155:20-7
  • Citrome L. Adjunctive aripiprazole, olanzapine, or quetiapine for major depressive disorder: an analysis of number needed to treat, number needed to harm, and likelihood to be helped or harmed. Postgrad Med 2010;122(4):39-48
  • Citrome L. Asenapine for schizophrenia and bipolar disorder: a review of the efficacy and safety profile for this newly approved sublingually absorbed second-generation antipsychotic. Int J Clin Pract 2009;63(12):1762-84
  • Merck & Co., Inc. Sahphris (asenapine) sublingual tablets. Prescribing information, revised March 2013. Available from: http://www.merck.com/product/usa/pi_circulars/s/saphris/saphris_pi.pdf [Accessed 19 January 2014]
  • Citrome L. Asenapine review, part I: chemistry, receptor affinity profile, pharmacokinetics and metabolism. Expert Opin Drug Metab Toxicol 2014;10(6):893-903
  • US Food and Drug Administration. Asenapine Drug Approval Package. October 2, 2009, updated December 18, 2009. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022117s000TOC.cfm [Accessed 20 January 2014]
  • US Food and Drug Administration. Saphris (Asenapine) Sublingual Tablets. Briefing Book. July 30, 2009. Available from: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/UCM173877.pdf [Accessed 26 January 2014]
  • Schering-Plough Research Institute. Saphris (Asenapine) Sublingual Tablets. Briefing Document (Background Package). July 30, 2009. Available from: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/UCM173876.pdf [Accessed 26 January 2014]
  • Potkin SG, Cohen M, Panagides J. Efficacy and tolerability of asenapine in acute schizophrenia: a placebo- and risperidone-controlled trial. J Clin Psychiatry 2007;68(10):1492-500
  • Kane JM, Cohen M, Zhao J, et al. Efficacy and safety of asenapine in a placebo- and haloperidol-controlled trial in patients with acute exacerbation of schizophrenia. J Clin Psychopharmacol 2010;30(2):106-15
  • Kane JM, Mackle M, Snow-Adami L, et al. A randomized placebo-controlled trial of asenapine for the prevention of relapse of schizophrenia after long-term treatment. J Clin Psychiatry 2011;72(3):349-55
  • Schoemaker J, Naber D, Vrijland P, et al. Long-term assessment of Asenapine vs. Olanzapine in patients with schizophrenia or schizoaffective disorder. Pharmacopsychiatry 2010;43(4):138-46
  • Schoemaker J, Stet L, Vrijland P, et al. Long-term efficacy and safety of asenapine or olanzapine in patients with schizophrenia or schizoaffective disorder: an extension study. Pharmacopsychiatry 2012;45(5):196-203
  • Alphs L, Panagides J, Lancaster S. Asenapine in the treatment of negative symptoms of schizophrenia: clinical trial design and rationale. Psychopharmacol Bull 2007;40(2):41-53
  • Buchanan RW, Panagides J, Zhao J, et al. Asenapine versus olanzapine in people with persistent negative symptoms of schizophrenia. J Clin Psychopharmacol 2012;32(1):36-45
  • McIntyre RS, Cohen M, Zhao J, et al. A 3-week, randomized, placebo-controlled trial of asenapine in the treatment of acute mania in bipolar mania and mixed states. Bipolar Disord 2009;11(7):673-86
  • McIntyre RS, Cohen M, Zhao J, et al. Asenapine in the treatment of acute mania in bipolar I disorder: a randomized, double-blind, placebo-controlled trial. J Affect Disord 2010;122(1-2):27-38
  • McIntyre RS, Cohen M, Zhao J, et al. Asenapine versus olanzapine in acute mania: a double-blind extension study. Bipolar Disord 2009;11(8):815-26
  • McIntyre RS, Cohen M, Zhao J, et al. Asenapine for long-term treatment of bipolar disorder: a double-blind 40-week extension study. J Affect Disord 2010;126(3):358-65
  • Szegedi A, Calabrese JR, Stet L, et al. Asenapine as adjunctive treatment for acute mania associated with bipolar disorder: results of a 12-week core study and 40-week extension. J Clin Psychopharmacol 2012;32(1):46-55
  • Friberg LE, de Greef R, Kerbusch T, Karlsson MO. Modeling and simulation of the time course of asenapine exposure response and dropout patterns in acute schizophrenia. Clin Pharmacol Ther 2009;86(1):84-91
  • Szegedi A, Verweij P, van Duijnhoven W, et al. Meta-analyses of the efficacy of asenapine for acute schizophrenia: comparisons with placebo and other antipsychotics. J Clin Psychiatry 2012;73(12):1533-40
  • Leucht S, Cipriani A, Spineli L, et al. Comparative efficacy and tolerability of 15 antipsychotic drugs in schizophrenia: a multiple-treatments meta-analysis. Lancet 2013;382(9896):951-62
  • Citrome L, Volavka J. Review: 15 antipsychotic drugs are more effective than placebo for the treatment of schizophrenia, but vary in their tolerability. Evid Based Ment Health 2014;17(1):9
  • Leucht S, Zhao J. Early improvement as a predictor of treatment response and remission in patients with Schizophrenia: a pooled, post-hoc analysis from the asenapine development program. J Psychopharmacol 2014;28(4):387-94
  • Potkin SG, Phiri P, Szegedi A, et al. Long-term effects of asenapine or olanzapine in patients with persistent negative symptoms of schizophrenia: a pooled analysis. Schizophr Res 2013;150(2-3):442-9
  • Cazorla P, Zhao J, Mackle M, Szegedi A. Asenapine effects on individual Young Mania Rating Scale items in bipolar disorder patients with acute manic or mixed episodes: a pooled analysis. Neuropsychiatr Dis Treat 2013;9:409-13
  • Szegedi A, Zhao J, van Willigenburg A, et al. Effects of asenapine on depressive symptoms in patients with bipolar I disorder experiencing acute manic or mixed episodes: a post hoc analysis of two 3-week clinical trials. BMC Psychiatry 2011;11:101
  • McIntyre RS, Tohen M, Berk M, et al. DSM-5 mixed specifier for manic episodes: evaluating the effect of depressive features on severity and treatment outcome using asenapine clinical trial data. J Affect Disord 2013;150(2):378-83
  • Azorin JM, Sapin C, Weiller E. Effect of asenapine on manic and depressive symptoms in bipolar I patients with mixed episodes: results from post hoc analyses. J Affect Disord 2013;145(1):62-9
  • Michalak EE, Guiraud-Diawara A, Sapin C. Asenapine treatment and health-related quality of life in patients experiencing bipolar I disorder with mixed episodes: post-hoc analyses of pivotal trials. Curr Med Res Opin 2014;30(4):711-18
  • Szegedi A, Zhao J, McIntyre RS. Early improvement as a predictor of acute treatment outcome in manic or mixed episodes in bipolar-1 disorder: a pooled, post hoc analysis from the asenapine development program. J Affect Disord 2013;150(3):745-52
  • Gao K, Mackle M, Cazorla P, et al. Comparison of somnolence associated with asenapine, olanzapine, risperidone, and haloperidol relative to placebo in patients with schizophrenia or bipolar disorder. Neuropsychiatr Dis Treat 2013;9:1145-57
  • Citrome L, Nasrallah HA. On-label on the table: what the package insert informs us about the tolerability profile of oral atypical antipsychotics, and what it does not. Expert Opin Pharmacother 2012;13(11):1599-613
  • Kemp DE, Zhao J, Cazorla P, et al. Weight change and metabolic effects of asenapine in patients with schizophrenia and bipolar disorder. J Clin Psychiatry 2014;75(3):238-45
  • Chapel S, Hutmacher MM, Haig G, et al. Exposure-response analysis in patients with schizophrenia to assess the effect of asenapine on QTc prolongation. J Clin Pharmacol 2009;49(11):1297-308
  • Chapel S, Hutmacher MM, Bockbrader H, et al. Comparison of QTc data analysis methods recommended by the ICH E14 guidance and exposure-response analysis: case study of a thorough QT study of asenapine. Clin Pharmacol Ther 2011;89(1):75-80
  • Schering-Plough. Saphris (asenapine) sublingual tablets. Prescribing information, as approved. 2009. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022117s000lbl.pdf [Accessed 30 January 2014]
  • Potkin SG. Dr Potkin Replies. J Clin Psychiatry 2012;73(5):720-1
  • US Food and Drug Administration. FDA drug safety communication: serious allergic reactions reported with the use of Saphris (asenapine maleate). September 1, 2011. Available from: http://www.fda.gov/Drugs/DrugSafety/ucm270243.htm [Accessed 30 January 2014]
  • Schering-Plough. Written response to medical query. File number 2009-34490. October 1, 2009
  • Gerrits M, de Greef R, Peeters P. Effect of absorption site on the pharmacokinetics of sublingual asenapine in healthy male subjects. Biopharm Drug Dispos 2010;31(5-6):351-7
  • Lundbeck. Sycrest 5mg and 10mg sublingual tablets. Summary of Product Characteristics. Last updated April 18, 2013. Available from: http://www.medicines.org.uk/emc/medicine/25632/SPC/Sycrest+5mg+and+10mg+sublingual+tablets/ [Accessed 2 February 2014]
  • Citrome L. A review of the pharmacology, efficacy and tolerability of recently approved and upcoming oral antipsychotics: an evidence-based medicine approach. CNS Drugs 2013;27(11):879-911
  • Pratts M, Citrome L, Grant W, et al. A single-dose, randomized, double-blind, placebo-controlled trial of sublingual asenapine for acute agitation. Acta Psychiatr Scand 2014; In press
  • Citrome L. Comparison of intramuscular ziprasidone, olanzapine, or aripiprazole for agitation: a quantitative review of efficacy and safety. J Clin Psychiatry 2007;68(12):1876-85
  • Cazorla P, Mackle M, Zhao J, et al. Safety and tolerability of switching to asenapine from other antipsychotic agents: pooled results from two randomized multicenter trials in stable patients with persistent negative symptoms in schizophrenia. Neuropsychiatr Dis Treat 2012;8:247-57
  • Minassian A, Young JW. Evaluation of the clinical efficacy of asenapine in schizophrenia. Expert Opin Pharmacother 2010;11(12):2107-15
  • Citrome L. Role of sublingual asenapine in treatment of schizophrenia. Neuropsychiatr Dis Treat 2011;7:325-39
  • Potkin SG. Asenapine: a clinical overview. J Clin Psychiatry 2011;72(Suppl 1):14-18
  • Pompili M, Serafini G, Innamorati M, et al. Unmet treatment needs in schizophrenia patients: is asenapine a potential therapeutic option? Expert Rev Neurother 2011;11(7):989-1006
  • Cortese L, Bressan RA, Castle DJ, Mosolov SN. Management of schizophrenia: clinical experience with asenapine. J Psychopharmacol 2013;27(4 Suppl):14-22
  • McIntyre RS. Pharmacology and efficacy of asenapine for manic and mixed states in adults with bipolar disorder. Expert Rev Neurother 2010;10(5):645-9
  • Pompili M, Venturini P, Innamorati M, et al. The role of asenapine in the treatment of manic or mixed states associated with bipolar I disorder. Neuropsychiatr Dis Treat 2011;7:259-65
  • McIntyre RS. Asenapine: a review of acute and extension phase data in bipolar disorder. CNS Neurosci Ther 2011;17(6):645-8
  • Gonzalez JM, Thompson PM, Moore TA. Review of the safety, efficacy, and side effect profile of asenapine in the treatment of bipolar 1 disorder. Patient Prefer Adherence 2011;5:333-41
  • Chwieduk CM, Scott LJ. Asenapine: a review of its use in the management of mania in adults with bipolar I disorder. CNS Drugs 2011;25(3):251-67
  • Young AH, Altamura AC, González-Pinto AM, et al. Use of asenapine in clinical practice for the management of bipolar mania. J Psychopharmacol 2013;27(4 Suppl):3-13
  • Warren CG, Dubovsky SL. New approaches for the management of bipolar disorder: role of sublingual asenapine in the treatment of mania. Neuropsychiatr Dis Treat 2013;9:753-8
  • Samalin L, Charpeaud T, Llorca PM. Asenapine in bipolar I disorder: evidence and place in patient management. Ther Adv Chronic Dis 2013;4(1):5-14
  • Fagiolini A, Forgione RN, Morana B, et al. Asenapine for the treatment of manic and mixed episodes associated with bipolar I disorder: from clinical research to clinical practice. Expert Opin Pharmacother 2013;14(4):489-504
  • Bishara D, Taylor D. Asenapine monotherapy in the acute treatment of both schizophrenia and bipolar I disorder. Neuropsychiatr Dis Treat 2009;5:483-90
  • Weber J, McCormack PL. Asenapine. CNS Drugs 2009;23(9):781-92
  • Tarazi FI, Shahid M. Asenapine maleate: a new drug for the treatment of schizophrenia and bipolar mania. Drugs Today (Barc) 2009;45(12):865-76
  • Stoner SC, Pace HA. Asenapine: a clinical review of a second-generation antipsychotic. Clin Ther 2012;34(5):1023-40
  • McIntyre RS, Wong R. Asenapine: a synthesis of efficacy data in bipolar mania and schizophrenia. Clin Schizophr Relat Psychoses 2012;5(4):217-20
  • van de Wetering-Krebbers SF, Jacobs PL, Kemperman GJ, et al. Metabolism and excretion of asenapine in healthy male subjects. Drug Metab Dispos 2011;39(4):580-90
  • Dubovsky SL, Frobose C, Phiri P, et al. Short-term safety and pharmacokinetic profile of asenapine in older patients with psychosis. Int J Geriatr Psychiatry 2012;27(5):472-82
  • Sun X, Hamer R, McEvoy J. Once daily dosing improves asenapine effectiveness, patient acceptance and adherence as compared to twice daily dosing. Poster presentation II-87. NCDEU; 28 – 31 May 2013; Hollywood, Florida

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