Drug updated on 3/28/2024
| Dosage Form | Tablet (oral; 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg) |
| Drug Class | Atypical antipsychotics |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults
- Treatment of schizophrenia in adults and pediatric patients ages 13 years and older.
- Treatment of agitation associated with dementia due to Alzheimer’s disease
Summary
- Brexpiprazole (Rexulti) is indicated for use as an adjunctive therapy to antidepressants in the treatment of major depressive disorder (MDD) in adults, and also for the treatment of schizophrenia in adults and pediatric patients aged 13 years or older.
- The systematic reviews/meta-analyses comprised a total of 17 documents that provided comprehensive data on brexpiprazole's effectiveness and safety primarily focusing on its use as an adjunct therapy for MDD and its role in treating schizophrenia.
- In comparison with other drugs such as lurasidone and cariprazine, brexpiprazole demonstrated comparable efficacy and safety when used to treat adult patients with schizophrenia; it exhibited a generally good safety profile despite variable outcomes.
- As an augmentation strategy for antidepressant-refractory depression, brexpiprazole showed efficacy at optimal dosing around 1-2 mg which balanced efficacy, tolerability, and acceptability without significantly impacting serious adverse events.
- For cases of Treatment-Resistant Depression (TRD), network meta-analysis suggested that brexpiprazole was among those drugs showing significant improvement compared to placebo thus indicating its utility even in resistant cases.
- A dose-response meta-analysis revealed that while some second-generation antipsychotics were associated with significant weight gain, this was not the case with brexpiprizol; instead it correlated mildly suggesting no linear correlation between higher doses leading to more weight gain making it favorable considering metabolic concerns associated many antipsychotic treatments.
- Specific subgroup considerations highlighted potential ethnic or regional differences: Japanese patients suffering from Schizophrenia responded effectively improving PANSS total scores when treated by Rexulti amongst other anti-psychotics although evidence confidence remained low due very low rating given during analysis process.
- Elderly Patients could potentially benefit from using Brexprizol since general indication suggests usage against agitation associated with Alzheimer's disease, however this area needs further exploration to evaluate its safety and efficacy in older subpopulations.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Rexulti (brexpiprazole) Prescribing Information. | 2021 | FDA |