Lurasidone hydrochloride

(Latuda®)

Latuda®

Drug updated on 9/4/2024

Dosage FormTablet (oral; 20 mg, 40 mg, 60 mg, 80 mg and 120 mg)
Drug ClassAtypical antipsychotics
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of schizophrenia in adults and adolescents (13 to 17 years).
  • Indicated for the treatment of depressive episode associated with bipolar I disorder (bipolar depression) in adults and pediatric patients (10 to 17 years) as monotherapy.
  • Indicated for the treatment of depressive episode associated with bipolar I disorder (bipolar depression) in adults as adjunctive therapy with lithium or valproate.

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Summary
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  • Latuda (lurasidone hydrochloride) is indicated for the treatment of schizophrenia in adults and adolescents (13 to 17 years), the treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults and pediatric patients (10 to 17 years) as monotherapy, and the treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults as adjunctive therapy with lithium or valproate.
  • This summary is based on the review of 21 systematic reviews/meta-analyses. [1-21]
  • Schizophrenia: Lurasidone 80, 120, and 160 mg significantly improved total PANSS scores compared to placebo (P<0.05), with no significant improvement observed at 40 mg. Additionally, significant improvements in CGI-S scores were noted with lurasidone at 80, 120, and 160 mg compared to placebo.
  • Bipolar Depression: Lurasidone significantly improved MADRS scores compared to placebo (-4.31, P=0.001), with higher response and remission rates. Lurasidone was effective in adolescents and young adults with bipolar depression and showed similar improvements in CDRS-R scores as olanzapine and quetiapine in youths aged 10-18 years.
  • Comparative Effectiveness: Lurasidone was comparable to brexpiprazole and cariprazine in schizophrenia treatment efficacy at 6 weeks, with 160 mg being superior in PANSS and CGI-S outcomes. In bipolar depression, lurasidone, olanzapine, and quetiapine all significantly improved MADRS scores compared to placebo.
  • Age and Dose Response: Lurasidone was effective in both adults and adolescents with schizophrenia and bipolar depression, with higher doses (80-160 mg) being more effective than lower doses for schizophrenia, particularly with the 160 mg dose showing the most significant improvements.
  • In schizophrenia, statistically significant adverse effects associated with lurasidone included agitation at 40 mg, vomiting at 80 mg, and akathisia at 160 mg, with common adverse events across doses including nausea, somnolence, and extrapyramidal symptoms.
  • In bipolar depression, lurasidone was associated with a higher incidence of akathisia, weight gain, and increased blood prolactin levels. Additionally, lurasidone showed a dose-dependent increase in the risk of akathisia, particularly at higher doses.
  • Compared to other antipsychotics, lurasidone demonstrated a more favorable metabolic profile, with less weight gain and smaller impacts on cholesterol and triglycerides, while maintaining a similar risk of somnolence.
  • Lurasidone is effective and safe for treating schizophrenia and bipolar depression in adults and adolescents (13-17 years for schizophrenia, 10-25 years for bipolar depression), with a favorable weight and metabolic profile particularly relevant in younger populations. There were no specific comorbid conditions mentioned in the studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Latuda (lurasidone hydrochloride) Prescribing Information.2022Sunovion Pharmaceuticals Inc., Marlborough, MA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Efficacy and tolerability of FDA-approved atypical antipsychotics for the treatment of bipolar depression: a systematic review and network meta-analysis.2024European Psychiatry
Efficacy and safety of lurasidone for schizophrenia: a systematic review and meta analysis of eight short term, randomized, double blind, placebo controlled clinical trials.2024Biomedical Reports
Systematic literature review and network meta-analysis of lurasidone, brexpiprazole and cariprazine for schizophrenia.2023International Clinical Pharmacology
Adverse effects of antipsychotics on sleep in patients with schizophrenia. Systematic review and meta-analysis.2023Frontiers in Psychiatry
Comparative effects of 11 antipsychotics on weight gain and metabolic function in patients with acute schizophrenia: a dose-response meta-analysis.2023The Journal of Clinical Psychiatry
Antipsychotic-induced akathisia in adults with acute schizophrenia: a systematic review and dose-response meta-analysis.2023European Neuropsychopharmacology
Effectiveness of atypical antipsychotics for unipolar and bipolar depression in adolescents and young adults: a systematic review and meta-analysis.2023Journal of Affective Disorders
A meta-analysis of antipsychotic-induced hypo- and hyperprolactinemia in children and adolescents.2022Journal of Child and Adolescent Psychopharmacology
Antipsychotic-induced weight gain: dose-response meta-analysis of randomized controlled trials.2022Schizophrenia Bulletin
Systematic review and network meta-analysis: efficacy and safety of second-generation antipsychotics in youths with bipolar depression.2022Journal of the American Academy of Child and Adolescent Psychiatry
A network meta‑analysis of the dose–response effects of lurasidone on acute schizophrenia.2021Scientific Reports
Differences in the incidence of lurasidone adverse events between depressive disorders and schizophrenia in double-blind, randomized, placebo-controlled trials: a meta-analysis.2021Psychopharmacology
Second-generation antipsychotic drugs for patients with schizophrenia: systematic literature review and meta-analysis of metabolic and cardiovascular side effects.2021Clinical Drug Investigation
Efficacy and tolerability of atypical antipsychotics for acute bipolar depression: a network meta-analysis.2021BMC Psychiatry
Efficacy and safety of lurasidone versus placebo as adjunctive to mood stabilizers in bipolar I depression: a meta-analysis.2020Journal of Affective Disorders
Efficacy, tolerability, and safety of lurasidone for acute schizophrenia: a systematic review and network meta-analysis of phase 3 trials in Japan.2020Neuropsychopharmacology Reports
A functional HTR1A polymorphism, rs6295, predicts short-term response to lurasidone: confirmation with meta-analysis of other antipsychotic drugs.2020The Pharmacogenomics Journal
Dose-response meta-analysis of antipsychotic drugs for acute schizophrenia.2020The American Journal of Psychiatry
Comparative effects of 18 antipsychotics on metabolic function in patients with schizophrenia, predictors of metabolic dysregulation, and association with psychopathology: a systematic review and network meta-analysis.2020Lancet Psychiatry
Lurasidone compared to other atypical antipsychotic monotherapies for adolescent schizophrenia: a systematic literature review and network meta-analysis.2020European Child & Adolescent Psychiatry
Lurasidone, olanzapine, and quetiapine extended-release for bipolar depression: a systematic review and network meta-analysis of phase 3 trials in Japan.2020Neuropsychopharmacology Reports

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