1. Costall, B, Domeney, AM, Kelly, ME, et al Actions of ORG 5222 as a novel psychotropic agent. Pharmacol Biochem Behav 1990; 35: 607–615.
Google Scholar | Crossref | Medline2. 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: 1762–1784.
Google Scholar | Crossref | Medline | ISI3. Citrome, L. Asenapine. In: Schatzberg, A, Nemeroff, C (eds). The APA publishing textbook of psychopharmacology. 5th ed. Arlington, VA: American Psychiatric Association Publishing, 2017, pp.797–808.
Google Scholar4. Noven . US FDA approves SECUADO® (asenapine) transdermal system, the first-and-only transdermal patch for the treatment of adults with schizophrenia. Press Release, 15 October 2019. https://www.noven.com/wp-content/uploads/2020/04/PR101519.pdf (2019, accessed 29 April 2021).
Google Scholar5. 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: 879–911.
Google Scholar | Crossref | Medline | ISI6. Shahid, M, Walker, GB, Zorn, SH, et al Asenapine: a novel psychopharmacologic agent with a unique human receptor signature. J Psychopharmacol 2009; 23: 65–73.
Google Scholar | SAGE Journals | ISI7. Citrome, L. Asenapine review, part I: chemistry, receptor affinity profile, pharmacokinetics and metabolism. Expert Opin Drug Metab Toxicol 2014; 10: 893–903.
Google Scholar | Crossref | Medline8. U.S. Food and Drug Administration . Saphris (asenapine) sublingual tablets full prescribing information, https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022117s020s021lbl.pdf (2017, accessed 4 March 2021).
Google Scholar9. 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: 351–357.
Google Scholar | Medline10. Dogterom, P, De Greef, R, Peeters, PA. The effect of food on the high clearance drug asenapine after sublingual administration to healthy male volunteers. Eur J Clin Pharmacol 2015; 71: 65–74.
Google Scholar | Crossref | Medline11. Suzuki, K, Castelli, M, Komaroff, M, et al Pharmacokinetic profile of the asenapine transdermal system (HP-3070). J Clin Psychopharmacol 2021; 41: 286–294.
Google Scholar | Crossref | Medline12. De Greef, R, Maloney, A, Olsson-Gisleskog, P, et al Dopamine D2 occupancy as a biomarker for antipsychotics: quantifying the relationship with efficacy and extrapyramidal symptoms. AAPS J 2011; 13: 121–130.
Google Scholar | Crossref | Medline | ISI13. Asenapine . Drugs and lactation database (LactMed). Bethesda, MD: National Library of Medicine, 2006.
Google Scholar14. 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: 1492–1500.
Google Scholar | Crossref | Medline | ISI15. 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: 106–115.
Google Scholar | Crossref | Medline | ISI16. Kay, SR, Fiszbein, A, Opler, LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull 1987; 13: 261–276.
Google Scholar | Crossref | Medline | ISI17. Findling, RL, Landbloom, RP, Mackle, M, et al Safety and efficacy from an 8 week double-blind trial and a 26 week open-label extension of asenapine in adolescents with schizophrenia. J Child Adolesc Psychopharmacol 2015; 25: 384–396.
Google Scholar | Crossref | Medline18. Kinoshita, T, Bai, YM, Kim, JH, et al Efficacy and safety of asenapine in Asian patients with an acute exacerbation of schizophrenia: a multicentre, randomized, double-blind, 6-week, placebo-controlled study. Psychopharmacology 2016; 233: 2663–2674.
Google Scholar | Crossref | Medline19. Landbloom, R, Mackle, M, Wu, X, et al Asenapine for the treatment of adults with an acute exacerbation of schizophrenia: results from a randomized, double-blind, fixed-dose, placebo-controlled trial with olanzapine as an active control. CNS Spectr 2017; 22: 333–341.
Google Scholar | Crossref | Medline20. Maitra, A, Bhattacharyya, S, Mukhopadhyay, S, et al A randomized controlled trial to compare the efficacy, safety and tolerability of asenapine versus olanzapine in management of schizophrenia. Clin Psychopharmacol Neurosci 2020; 18: 587–598.
Google Scholar | Crossref | Medline21. Citrome, L, Walling, DP, Zeni, CM, et al Efficacy and safety of HP-3070, an asenapine transdermal system, in patients with schizophrenia: a phase 3, randomized, placebo-controlled study. J Clin Psychiatry 2020; 82: 20m13602.
Google Scholar | Crossref | Medline22. 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: 1533–1540.
Google Scholar | Crossref | Medline | ISI23. Guy, W. Clinical global impressions. In: Guy, W (ed.) ECDEU assessment manual for psychopharmacology. Washington, DC: US Department of Health, Education, and Welfare, 1976, pp. 217–222.
Google Scholar24. Overall, JE, Gorham, DR. The brief psychiatric rating scale. Psychol Rep 1962; 10: 799–812.
Google Scholar | SAGE Journals | ISI25. 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: 349–355.
Google Scholar | Crossref | Medline | ISI26. 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: 138–146.
Google Scholar | Crossref | Medline | ISI27. 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: 196–203.
Google Scholar | Medline | ISI28. Addington, D, Addington, J, Schissel, B. A depression rating scale for schizophrenics. Schizophr Res 1990; 3: 247–251.
Google Scholar | Crossref | Medline | ISI29. Buchanan, RW, Panagides, J, Zhao, J, et al Asenapine versus olanzapine in people with persistent negative symptoms of schizophrenia. J Clin Psychopharmacol 2012; 32: 36–45.
Google Scholar | Crossref | Medline | ISI30. Alphs, LD, Summerfelt, A, Lann, H, et al The negative symptom assessment: a new instrument to assess negative symptoms of schizophrenia. Psychopharmacol Bull 1989; 25: 159–163.
Google Scholar | Medline31. 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: 673–686.
Google Scholar | Crossref | Medline | ISI32. 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: 27–38.
Google Scholar | Crossref | Medline | ISI33. McIntyre, RS, Cohen, M, Zhao, J, et al Asenapine versus olanzapine in acute mania: a double-blind extension study. Bipolar Disord 2009; 11: 815–826.
Google Scholar | Crossref | Medline | ISI34. 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: 358–365.
Google Scholar | Crossref | Medline | ISI35. Young, RC, Biggs, JT, Ziegler, VE, et al A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry 1978; 133: 429–435.
Google Scholar | Crossref | Medline | ISI36. McIntyre, RS, Wong, R. Asenapine: a synthesis of efficacy data in bipolar mania and schizophrenia. Clin Schizophr Relat Psychoses 2012; 5: 217–220.
Google Scholar | Crossref | Medline37. Landbloom, RL, Mackle, M, Wu, X, et al Asenapine: efficacy and safety of 5 and 10mg bid in a 3-week, randomized, double-blind, placebo-controlled trial in adults with a manic or mixed episode associated with bipolar I disorder. J Affect Disord 2016; 190: 103–110.
Google Scholar | Crossref | Medline38. Ketter, TA, Durgam, S, Landbloom, R, et al Long-term safety and tolerability of asenapine: a double-blind, uncontrolled, long-term extension trial in adults with an acute manic or mixed episode associated with bipolar I disorder. J Affect Disord 2017; 207: 384–392.
Google Scholar | Crossref | Medline39. Findling, RL, Landbloom, RL, Szegedi, A, et al Asenapine for the acute treatment of pediatric manic or mixed episode of bipolar I disorder. J Am Acad Child Adolesc Psychiatry 2015; 54: 1032–1041.
Google Scholar | Crossref | Medline40. Findling, RL, Landbloom, RL, Mackle, M, et al Long-term safety of asenapine in pediatric patients diagnosed with bipolar i disorder: a 50-week open-label, flexible-dose trial. Paediatr Drugs 2016; 18: 367–378.
Google Scholar | Crossref | Medline41. Baruch, Y, Tadger, S, Plopski, I, et al Asenapine for elderly bipolar manic patients. J Affect Disord 2013; 145: 130–132.
Google Scholar | Crossref | Medline42. Spearing, MK, Post, RM, Leverich, GS, et al Modification of the clinical global impressions (CGI) scale for use in bipolar illness (BP): the CGI-BP. Psychiatry Res 1997; 73: 159–171.
Google Scholar | Crossref | Medline | ISI43. Barak, Y, Finkelstein, I, Pridan, S. The geriatric mania asenapine study (GeMS). Arch Gerontol Geriatr 2016; 64: 111–114.
Google Scholar | Crossref | Medline | ISI44. Szegedi, A, Durgam, S, Mackle, M, et al Randomized, double-blind, placebo-controlled trial of asenapine maintenance therapy in adults with an acute manic or mixed episode associated with bipolar I disorder. Am J Psychiatry 2018; 175: 71–79.
Google Scholar | Crossref | Medline45. Montgomery, SA, Asberg, M. A new depression scale designed to be sensitive to change. Br J Psychiatry 1979; 134: 382–389.
Google Scholar | Crossref | Medline | ISI46. 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: 46–55.
Google Scholar | Crossref | Medline | ISI47. Sajatovic, M, Dines, P, Fuentes-Casiano, E, et al Asenapine in the treatment of older adults with bipolar disorder. Int J Geriatr Psychiatry 2015; 30: 710–719.
Google Scholar | Crossref | Medline48. Hamilton, M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960; 23: 56–62.
Google Scholar