Brexpiprazole

(Rexulti®)

Rexulti®

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Drug updated on 5/17/2024

Dosage FormTablet (oral; 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg)
Drug ClassAntipsychotics
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.

Summary
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  • Brexpiprazole (Rexulti) is recommended for use alongside antidepressants for the management of major depressive disorder in adults, schizophrenia in adults and pediatric patients aged 13 years and older, and agitation associated with dementia due to Alzheimer's disease.
  • Nineteen studies provided detailed analyses comparing brexpiprazole with other drugs such as aripiprazole and cariprazine regarding effectiveness and safety profiles.
  • One study indicated that brexpiprazole might be effective at lower doses compared to aripiprazole in treating treatment-resistant depression, with the maximum effective dose being slightly lower (1.6 mg vs. 5.5 mg).
  • In Japanese populations with Major Depressive Disorder, brexpiprazole showed comparable efficacy and safety profiles to aripiprazole but was associated with a risk of weight gain, especially at doses higher than 2mg/day.
  • In the management of schizophrenia, lurasidone was found to be more effective compared to both brexpiprazole and cariprazine, suggesting it might be a preferable option, though brexpiprazole remains a viable alternative.
  • As an adjunct therapy for refractory cases of Major Depressive Disorder, Rexulti was effective up to doses of 2mg while maintaining a balance between efficacy, tolerability, and acceptability.
  • Brexpiprazole has been shown to cause mild weight gain (<1kg), suggesting it may have a better profile compared to antipsychotics that lead to significant weight gains, making it preferable for patients concerned about weight gain.
  • In comparison, the association of brexpiprazole with akathisia seems less risky than cariprazine but similar or slightly more than aripiprazole, hence careful monitoring is recommended during its use.

Product Monograph / Prescribing Information

Document TitleYearSource
Rexulti (brexpiprazole) Prescribing Information.2023Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Comparative efficacy of dopamine partial agonists by doses for treatment-resistant depression: a systematic review and dose-response model-based network meta-analysis.2024Journal of Clinical Psychopharmacology
Comparison of brexpiprazole, aripiprazole, and placebo for Japanese major depressive disorder: a systematic review and network meta-analysis.2024Neuropsychopharmacology Reports
Systematic literature review and network meta-analysis of lurasidone, brexpiprazole and cariprazine for schizophrenia.2023International Clinical Psychopharmacology
Comparative efficacy and safety of 4 atypical antipsychotics augmentation treatment for major depressive disorder in adults: a systematic review and network meta-analysis.2023Medicine
Efficacy and acceptability of second-generation antipsychotics with antidepressants in unipolar depression augmentation: a systematic review and network meta-analysis.2022Psychological Medicine
Antipsychotic-induced weight gain: dose-response meta-analysis of randomized controlled trials.2022The Journal of Psychoses and Related Disorders
Efficacy and safety/tolerability of antipsychotics in the treatment of adult patients with major depressive disorder: a systematic review and meta-analysis.2022Psychological Medicine
Optimal dose of brexpiprazole for augmentation therapy of antidepressant-refractory depression: a systematic review and dose-effect meta-analysis.2022Psychiatry and Clinical Neurosciences
Efficacy and safety of adjunctive serotonin-dopamine activity modulators in major depression: a meta-analysis of randomized controlled trials.2022Journal of Clinical Pharmacology
Augmentation strategies for treatment resistant major depression: a systematic review and network meta-analysis.2022Journal of Affective Disorders
Efficacy and safety of antipsychotic treatments for schizophrenia: a systematic review and network meta-analysis of randomized trials in Japan.2021Journal of Psychiatric Research
Efficacy and tolerability of combination treatments for major depression: antidepressants plus second-generation antipsychotics vs. esketamine vs. lithium.2021Journal of Psychopharmacology
Efficacy and safety of antipsychotic treatments for schizophrenia: a systematic review and network meta-analysis of randomized trials in Japan.2021Journal of Psychiatric Research
Dose-response meta-analysis of antipsychotic drugs for acute schizophrenia.2020The American Journal of Psychiatry
Comparative effects of 18 antipsychotics on metabolic function in patients with schizophrenia, predictors of metabolic dysregulation, and association with psychopathology: a systematic review and network meta-analysis.2020Lancet Psychiatry
Blonanserin patch vs. other antipsychotics for acute schizophrenia: a systematic review of double-blind, randomized, placebo-controlled, phase 3 trials in Japan.2020Pharmacopsychiatry
Aripiprazole vs. brexpiprazole for acute schizophrenia: a systematic review and network meta-analysis.2020Psychopharmacology
Brexpiprazole as adjunctive treatment for major depressive disorder following treatment failure with at least one antidepressant in the current episode: a systematic review and meta-analysis.2019International Journal of Neuropsychopharmacology
Comparative efficacy and tolerability of 32 oral antipsychotics for the acute treatment of adults with multi-episode schizophrenia: a systematic review and network meta-analysis.2019Lancet
Medication-induced akathisia with newly approved antipsychotics in patients with a severe mental illness: a systematic review and meta-analysis.2019CNS Drugs