Abstract
Lurasidone is a newer “atypical” or “secondgeneration” antipsychotic that has received regulatory approval in the US and Canada for the treatment of schizophrenia. Recent changes in lurasidone product labeling include an expansion of the recommended dose range from 40–80 mg/day to 40–160 mg/day, administered once-daily with food. The recommended starting dose is 40 mg/day. Initial dose titration is not required. Efficacy for the treatment of acute episodes of schizophrenia was established in five, 6-week, fixed-dose, randomized, placebo-controlled trials. Additional short-term studies in patients with schizophrenia include a 3-week, randomized, double-blind trial comparing lurasidone with ziprasidone on safety and tolerability outcomes, and a 6-week, randomized, open-label switch study. Available long-term data includes a 12-month, doubleblind safety and tolerability study comparing lurasidone with risperidone; a 6-month, openlabel extension study for one of the shortterm registration studies where patients were initially randomized to receive lurasidone, olanzapine, or placebo; and a 12-month, doubleblind extension study comparing lurasidone with quetiapine extended-release after having received lurasidone, quetiapine extendedrelease, or placebo for 6 weeks. The totality of the evidence supports the overall tolerability of lurasidone, with minimal weight gain and no clinically-meaningful alterations in glucose, lipids, or the electrocardiogram corrected QT (ECG QTc) interval. The most commonly encountered adverse events that can be observed with lurasidone are somnolence, akathisia, nausea, and parkinsonism. Additional clinical trials are underway for the use of lurasidone in patients with bipolar disorder, including major depressive episodes in patients with bipolar I disorder, and in bipolar and schizophrenia maintenance. Principal advantages over some other second-generation antipsychotics are lurasidone’s highly favorable metabolic profile and once-daily dosing regimen. Additional studies are desirable to directly compare and contrast lurasidone’s efficacy with other antipsychotic agents.
Article PDF
Similar content being viewed by others
Avoid common mistakes on your manuscript.
References
United States Food and Drug Administration. FDA approves Latuda to treat schizophrenia in adults. Press release, October 28, 2010. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm231512.htm. Accessed Jun 20 2012.
Sunovion Pharmaceuticals Canada Inc. Sunovion Pharmaceuticals Canada Inc. announces Health Canada approval of once-daily LATUDA? (lurasidone HCl) for the treatment of patients with schizophrenia. Press release, June 15, 2012. Available at: http://www.sunovion.ca/news/pressReleases/20120615.pdf. Accessed Jun 20 2012.
Sunovion Pharmaceuticals Inc. Latuda: US Package Insert for Latuda (lurasidone HCl) tablets for oral use. May 2012. Available at: http://www.latuda.com/LatudaPrescribingInformation.pdf. Accessed Sept 5 2012.
Sunovion Pharmaceuticals Canada Inc. Latuda: Product Monograph for Latuda (lurasidone HCl) 40 mg, 80 mg and 120 mg film-coated tablets. 18 June 2012. Available at: http://www.sunovion.ca/monographs/latuda.pdf. Accessed Jun 20 2012.
Volavka J, Citrome L. Oral antipsychotics for the treatment of schizophrenia: heterogeneity in efficacy and tolerability should drive decision-making. Expert Opin Pharmacother. 2009;10:1917–1928.
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.
Citrome L. Lurasidone for schizophrenia: a brief review of a new second-generation antipsychotic. Clin Schizophr Relat Psychoses. 2011;4:251–257.
Kantrowitz JT, Citrome L. Lurasidone for schizophrenia: what’s different? Expert Rev Neurother. 2012;12:265–273.
Meyer JM, Loebel AD, Schweizer E. Lurasidone: a new drug in development for schizophrenia. Expert Opin Investig Drugs. 2009;18:1715–1726.
Citrome L. Using oral ziprasidone effectively: the food effect and dose-response. Adv Ther. 2009;26:739–748.
Nakamura M, Ogasa M, Guarino J, et al. Lurasidone in the treatment of acute schizophrenia: a doubleblind, placebo-controlled trial. J Clin Psychiatry. 2009;70:829–836.
Meltzer HY, Cucchiaro J, Silva R, et al. Lurasidone in the treatment of schizophrenia: a randomized, double-blind, placebo- and olanzapine-controlled study. Am J Psychiatry. 2011;168:957–967.
Ogasa M, Kimura T, Nakamura M, Guarino J. Lurasidone in the treatment of schizophrenia: a 6-week, placebo-controlled study. Psychopharmacology (Berl). 2012. [Epub ahead of print].
Loebel A, Cucchiaro J, Pikalov A, et al. Lurasidone in the treatment of acute schizophrenia: results of the double-blind, placebo-controlled, 6-week, PEARL 3 trial. Neuropsychopharmacology. 2011;35(Suppl. 1):S313–S314.
United States Food and Drug Administration. Drug approval package. Latuda (lurasidone hydrochloride) tablets. Available at: www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200603Orig1s000TOC.cfm. Accessed Jun 20 2012.
Potkin S, Ogasa M, Cucchiaro J, Loebel A. Doubleblind comparison of the safety and efficacy of lurasidone and ziprasidone in clinically stable outpatients with schizophrenia or schizoaffective disorder. Schizophr Res. 2011;132:101–107.
Citrome L. Lurasidone for the acute treatment of adults with schizophrenia: what is the number needed to treat, number needed to harm and likelihood to be helped or harmed? Clin Schizophr Relat Psychoses. 2012;6:76–85.
McEvoy JP, Citrome L, Hernandez D, et al. Switching to lurasidone in patients with schizophrenia: tolerability and effectiveness of three switch strategies. Poster Presentation NR6-46, American Psychiatric Association 165th Annual Meeting; May 5–9, 2012; Philadelphia, PA.
Citrome L, Cucchiaro J, Sarma K, et al. Longterm safety and tolerability of lurasidone in schizophrenia: a 12-month, double-blind, activecontrolled study. Int Clin Psychopharmacol. 2012;27:165–176.
Loebel A, Cucchiaro J, Xu J, Sarma K, Pikalov A, Kane JM. Effectiveness of lurasidone vs. quetiapine XR for relapse prevention in schizophrenia: a 12-month, double-blind study. Poster Presentation NR6-36, American Psychiatric Association 165th Annual Meeting; May 5–9, 2012; Philadelphia, PA.
Stahl SM, Cucchiaro J, Simonelli D, Severs J, Loebel A. Long-term safety and tolerability of lurasidone in patients with schizophrenia: results of a 6-month, open-label extension study. Poster Presentation NR6-58, American Psychiatric Association 164th Annual Meeting; May 14–18, 2011; Honolulu, HI.
Citrome L. Iloperidone, asenapine and lurasidone. A brief overview of three new second-generation antipsychotics. Postgrad Med. 2011;123(2):153–162.
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;13:1599–1613.
Loebel A, Cucchiaro J, Silva R, et al. Lurasidone monotherapy for the treatment of bipolar I depression: results of a 6-week, double-blind, placebo-controlled study. Poster Presentation NR4-58, American Psychiatric Association 165th Annual Meeting; May 5–9, 2012; Philadelphia, PA.
Loebel A, Cucchiaro J, Silva R, et al. Lurasidone adjunctive to lithium or valproate for the treatment of bipolar I depression: results of a 6-week, double-blind, placebo-controlled study. Poster Presentation NR4-29, American Psychiatric Association 165th Annual Meeting; May 5–9, 2012; Philadelphia, PA.
Author information
Authors and Affiliations
Corresponding author
Additional information
To view enhanced content go to www.advancesintherapy.com
Rights and permissions
About this article
Cite this article
Citrome, L. Lurasidone in Schizophrenia: New Information About Dosage and Place in Therapy. Adv Therapy 29, 815–825 (2012). https://doi.org/10.1007/s12325-012-0052-6
Received:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s12325-012-0052-6