Drug updated on 10/31/2024
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
- Indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults
- Indicated for the treatment of schizophrenia in adults and pediatric patients ages 13 years and older
- Indicated for the treatment of agitation associated with dementia due to Alzheimers disease.
Latest News
Summary
- This summary is based on the review of 16 systematic review(s)/meta-analysis(es). [1-16]
- Schizophrenia Management: Brexpiprazole significantly reduced PANSS (Positive and Negative Syndrome Scale) scores compared to placebo and demonstrated similar efficacy to aripiprazole. However, it was found to be less effective than risperidone and equally effective as olanzapine in treating acute mania.
- Major Depressive Disorder (MDD): As an adjunct treatment, brexpiprazole showed significant improvements on the Montgomery-Asberg Depression Rating Scale (MADRS), Sheehan Disability Scale (SDS), and Hamilton Depression Rating Scale (HDRS17) in adults inadequately responsive to antidepressants. Optimal dosing of 1-2 mg improved the risk-benefit balance compared to other antipsychotic adjuncts.
- Behavioral and Psychological Symptoms of Dementia (BPSD): Brexpiprazole was significantly more effective than placebo in reducing agitation symptoms in Alzheimer’s patients, as measured by the Cohen-Mansfield Agitation Inventory (CMAI) and Clinical Global Impression - Severity of illness (CGI-S) score, and was more efficacious than quetiapine, olanzapine, and aripiprazole.
- Patient Populations: The studies included diverse populations, with adults having schizophrenia and MDD, as well as patients with Alzheimer’s disease experiencing agitation; specific subgroup findings were not detailed in the studies.
- Common Adverse Events: Brexpiprazole was associated with side effects including akathisia, weight gain, and somnolence, with these effects being dose-dependent; higher doses correlated with increased risk.
- Serious Adverse Events: There was no significant difference in the incidence of serious adverse events or all-cause mortality between brexpiprazole and placebo in patients with Alzheimer’s disease.
- Comparison with Other Drugs: Brexpiprazole demonstrated a better safety profile regarding falls and sedation compared to olanzapine in treating behavioral and psychological symptoms of dementia (BPSD), while also exhibiting fewer intolerability-related discontinuations than aripiprazole and quetiapine in major depressive disorder (MDD).
- Brexpiprazole was effective in managing schizophrenia, major depressive disorder (MDD), and behavioral and psychological symptoms of dementia (BPSD), with studies including a broad range of patients; optimal dosing in MDD was noted at 1-2 mg for a better risk-benefit balance, particularly in adults inadequately responsive to antidepressants.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Rexulti (brexpiprazole) Prescribing Information. | 2024 | Otsuka America Pharmaceutical, Inc., Princeton, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Canadian Clinical Practice Guidelines for Assessing and Managing Behavioural and Psychological Symptoms of Dementia (BPSD) | 2024 | Canadian Coalition for Seniors' Mental Health |