Drug updated on 9/4/2024
| Dosage Form | Tablet (oral; 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg) |
| Drug Class | 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 Alzheimer’s disease.
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Summary
- Rexulti (brexpiprazole) is indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults; for the treatment of schizophrenia in adults and pediatric patients ages 13 years and older; and for the treatment of agitation associated with dementia due to Alzheimer’s disease.
- This summary is based on the review of 20 systematic review(s)/meta-analysis(es). [1-20]
- Treatment-Resistant Depression: Aripiprazole (max 5.5 mg) was more effective than brexpiprazole (max 1.6 mg) and cariprazine (max 1.5 mg) in treatment-resistant depression. Brexpiprazole at 1-3 mg was more effective than cariprazine 0.5 mg, but no dose of brexpiprazole was more effective than aripiprazole.
- Major Depressive Disorder (MDD) in Japanese Population: Brexpiprazole (1 mg/day and 2 mg/day) and aripiprazole were effective compared to placebo in MDD, with brexpiprazole showing efficacy but also an increased risk of weight gain.
- Schizophrenia: Lurasidone (160 mg) was superior to brexpiprazole and cariprazine in reducing PANSS and CGI-S scores in schizophrenia. Brexpiprazole showed comparable efficacy to other antipsychotics for schizophrenia.
- General Efficacy in MDD: Brexpiprazole was effective as an adjunctive treatment for MDD, but risperidone and aripiprazole were more efficacious and better accepted than brexpiprazole.
- Both brexpiprazole and aripiprazole showed higher risks of akathisia and weight gain compared to placebo, with brexpiprazole also leading to higher discontinuation rates due to adverse events.
- Brexpiprazole caused mild weight gain (≤1 kg) and demonstrated a higher incidence of significant weight gain compared to cariprazine and asenapine, with similar tolerability issues observed in quetiapine, olanzapine, and risperidone.
- In the Japanese population with schizophrenia, brexpiprazole's safety profile mirrored global findings, highlighting increased risks of akathisia, weight gain, and discontinuation due to adverse events.
- There is no population type or subgroup information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Rexulti (brexpiprazole) Prescribing Information. | 2023 | Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan |