Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 20 mg, 40 mg, 60 mg, 80 mg and 120 mg) |
Drug Class | Atypical 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
- 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 Title | Year | Source |
---|---|---|
Latuda (lurasidone hydrochloride) Prescribing Information. | 2022 | Sunovion Pharmaceuticals Inc., Marlborough, MA |