Drug updated on 5/17/2024
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
- 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 Title | Year | Source |
---|---|---|
Latuda (lurasidone hydrochloride) Prescribing Information. | 2022 | Sunovion Pharmaceuticals Inc., Marlborough, MA |