Lurasidone hydrochloride

(Latuda®)

Latuda®

Drug updated on 5/17/2024

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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  • Lurasidone hydrochloride (Latuda) is indicated for the treatment of schizophrenia in adults and adolescents aged 13 to 17 years, as well as depressive episodes associated with bipolar I disorder in adults and pediatric patients aged 10 to 17 years. It can be used both as monotherapy or in conjunction with lithium or valproate.
  • A review of 21 systematic reviews/meta-analyses provided insights into the efficacy, safety profiles, specifics of the population, and subgroup considerations related to lurasidone hydrochloride.
  • In managing schizophrenia, doses ranging from 80-160mg/day were significantly effective in symptom improvement, including reductions in Positive and Negative Syndrome Scale scores, outperforming placebo and comparable or superior to other atypical antipsychotics such as brexpiprazole and cariprazine at certain doses.
  • For depressive episodes associated with bipolar I disorder, lurasidone was effective both as a standalone treatment and when combined with lithium or valproate, notably improving Montgomery Åsberg Depression Rating Scale scores and achieving higher remission rates compared to other US FDA-approved atypical antipsychotics for bipolar depression.
  • Lurasidone demonstrated a minimal impact on weight gain and metabolic parameters such as cholesterol levels, signaling its favorable metabolic profile which is crucial for long-term management and reducing cardiovascular risk among patients. This aspect makes lurasidone an attractive option, enhancing treatment adherence due to minimal side effects over periods extending beyond initial clinical trials.
  • The common adverse effects associated with lurasidone are akathisia, nausea, somnolence, and extrapyramidal disorders. Its profile, however, remains generally favorable with lower incidences of significant weight gain and less severe metabolic disturbances compared to drugs like olanzapine.
  • Lurasidone has proven to be effective and well-tolerated in younger populations, including adolescents with schizophrenia or bipolar depression, with a safety profile relevant to metabolic effects and weight management, especially crucial for this group at higher risk for such side effects.
  • Evidence indicates a dose-response relationship regarding efficacy and adverse effects, with higher doses (up to 160mg/day) more efficacious but also linked to higher risks for akathisia among other side effects, underscoring the importance of dose optimization.

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

Clinical Practice Guidelines