Lurasidone hydrochloride

(Latuda®)

Latuda®

Drug updated on 12/11/2024

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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  • This summary is based on the review of 28 systematic review(s)/meta-analysis(es). [1-28]
  • Lurasidone significantly improved the Montgomery Asberg Depression Rating Scale (MADRS) score versus placebo (-4.71, 95% credible interval (CrI) -6.98 to -2.41) and showed higher response (relative risk (RR) 0.78, 95% confidence interval (CI) 0.66 to 0.92) and remission rates (RR 0.90, 95% CI 0.83 to 0.98).
  • In Clinical Global Improvement - Bipolar Disorder (CGI-BP) scores, lurasidone demonstrated greater efficacy compared to cariprazine and ziprasidone but similar outcomes to quetiapine and olanzapine.
  • Lurasidone displayed superior odds of response versus cariprazine, aripiprazole, and ziprasidone and was effective in adolescents, showing significant improvements in the Positive and Negative Symptom Scale (PANSS) and Clinical Global Impression (CGI-S) scores for schizophrenia and comparable efficacy to olanzapine-fluoxetine in bipolar depression.
  • Lurasidone effectively prevented mood episode recurrence when combined with mood stabilizers and had lower odds of all-cause discontinuation compared to aripiprazole and paliperidone extended release (ER).
  • Lurasidone demonstrated minimal weight change (0.34 kg [95% CrI -0.22, 0.89]) relative to placebo and showed significantly less weight gain than olanzapine and quetiapine. In adolescent populations, lurasidone was associated with lower weight gain compared to other antipsychotics.
  • Lurasidone had lower increases in cholesterol and triglycerides than olanzapine and quetiapine, with minimal effects on glucose and prolactin levels.
  • Adverse events associated with lurasidone included a higher incidence of akathisia, nausea, and somnolence compared to placebo, with a similar safety profile to other antipsychotics in terms of extrapyramidal symptoms (EPS) and akathisia rates.
  • Lurasidone was effective and well-tolerated in adolescents with schizophrenia, showing significant improvements in PANSS and CGI-S scores, and exhibited a favorable safety profile with lower weight gain compared to other antipsychotics.

Product Monograph / Prescribing Information

Document TitleYearSource
Latuda (lurasidone hydrochloride) Prescribing Information.2022Sumitomo Pharma America, 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-analysis2024European Psychiatry : The Journal Of The Association Of European Psychiatrists
Efficacy and safety of lurasidone for schizophrenia: A systematic review and meta‑analysis of eight short‑term, randomized, double‑blind, placebo‑controlled clinical trials2024Biomedical Reports
Real-World Effectiveness, Economic, and Humanistic Outcomes of Selected Oral Antipsychotics in Patients with Schizophrenia: A Systematic Review Evaluating Global Evidence2024Clinicoeconomics And Outcomes Research : Ceor
Comparative physiological effects of antipsychotic drugs in children and young people: a network meta-analysis2024The Lancet. Child & Adolescent Health
Adverse effects of antipsychotics on sleep in patients with schizophrenia. Systematic review and meta-analysis2023Frontiers In Psychiatry
Does short-term antipsychotic discontinuation of up to 3 weeks worsen symptoms in acute schizophrenia? A pooled analysis of placebo washout data2023Psychiatry And Clinical Neurosciences
Effectiveness of atypical antipsychotics for unipolar and bipolar depression in adolescents and young adults: A systematic review and meta-analysis2023Journal Of Affective Disorders
Long-term efficacy of antipsychotic drugs in initially acutely ill adults with schizophrenia: systematic review and network meta-analysis2023World Psychiatry : Official Journal Of The World Psychiatric Association (Wpa)
Systematic literature review and network meta-analysis of lurasidone, brexpiprazole and cariprazine for schizophrenia2023International Clinical Psychopharmacology
Antipsychotic-induced akathisia in adults with acute schizophrenia: A systematic review and dose-response meta-analysis2023European Neuropsychopharmacology : The Journal Of The European College Of
Antipsychotic-Induced Weight Gain: Dose-Response Meta-Analysis of Randomized Controlled Trials2022Schizophrenia Bulletin
Systematic Review and Network Meta-analysis: Efficacy and Safety of Second-Generation Antipsychotics in Youths With Bipolar Depression2022Journal Of The American Academy Of Child And Adolescent Psychiatry
Effects of antipsychotics on heart rate in treatment of schizophrenia: a systematic review and meta-analysis2022Therapeutic Advances In Psychopharmacology
Cost-utility analysis of lurasidone for the first-line treatment of schizophrenia in China2022Frontiers In Public Health
Efficacy and tolerability of atypical antipsychotics for acute bipolar depression: a network meta-analysis2021Bmc Psychiatry
Second-Generation Antipsychotic Drugs for Patients with Schizophrenia: Systematic Literature Review and Meta-analysis of Metabolic and Cardiovascular Side Effects2021Clinical Drug Investigation
A network meta-analysis of the dose-response effects of lurasidone on acute schizophrenia2021Scientific Reports
Efficacy and safety of antipsychotic treatments for schizophrenia: A systematic review and network meta-analysis of randomized trials in Japan2021Journal Of Psychiatric Research
Real-World Data on the Adverse Metabolic Effects of Second-Generation Antipsychotics and Their Potential Determinants in Adult Patients: A Systematic Review of Population-Based Studies2021Advances In Therapy
Effects of a conventional mood stabilizer alone or in combination with second-generation antipsychotics on recurrence rate and discontinuation rate in bipolar I disorder in the maintenance phase: A systematic review and meta-analysis of randomized, placebo-controlled trials2021Bipolar Disorders
Mood stabilizers and/or antipsychotics for bipolar disorder in the maintenance phase: a systematic review and network meta-analysis of randomized controlled trials2021Molecular Psychiatry
Lurasidone, olanzapine, and quetiapine extended-release for bipolar depression: A systematic review and network meta-analysis of phase 3 trials in Japan2020Neuropsychopharmacology Reports
Lurasidone compared to other atypical antipsychotic monotherapies for adolescent schizophrenia: a systematic literature review and network meta-analysis2020European Child & Adolescent Psychiatry
Efficacy and safety of lurasidone versus placebo as adjunctive to mood stabilizers in bipolar I depression: A meta-analysis2020Journal Of Affective Disorders
Efficacy, tolerability, and safety of lurasidone for acute schizophrenia: A systematic review and network meta-analysis of phase 3 trials in Japan2020Neuropsychopharmacology Reports
Second Generation Antipsychotics Monotherapy as Maintenance Treatment for Bipolar Disorder: a Systematic Review of Long-Term Studies2020The Psychiatric Quarterly
Acceptability of Acute and Maintenance Pharmacotherapy of Bipolar Disorder: A Systematic Review of Randomized, Double-Blind, Placebo-Controlled Clinical Trials2020Journal Of Clinical Psychopharmacology
Dose-Response Meta-Analysis of Antipsychotic Drugs for Acute Schizophrenia2020The American Journal Of Psychiatry

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