What are the FDA (Food and Drug Administration)-approved uses for Rexulti (brexpiprazole)?

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From the FDA Drug Label

Adjunctive Treatment of Major Depressive Disorder (MDD) and Schizophrenia Of the total number of brexpiprazole-treated patients in the clinical studies for the adjunctive therapy to antidepressants for MDD and for schizophrenia

The FDA-approved uses for Rexulti (brexpiprazole) are:

  • Adjunctive treatment of Major Depressive Disorder (MDD)
  • Treatment of Schizophrenia 1

From the Research

Rexulti (brexpiprazole) is FDA-approved for the treatment of schizophrenia in adults and adolescents aged 13 and older, and as an adjunctive treatment for major depressive disorder (MDD) in adults when used alongside antidepressants. The medication works as an atypical antipsychotic by acting as a partial agonist at serotonin 5-HT1A and dopamine D2 receptors, and as an antagonist at serotonin 5-HT2A receptors, helping to balance neurotransmitters in the brain 2. For MDD, Rexulti is prescribed when patients have had an inadequate response to antidepressant therapy alone, typically starting at 0.5-1 mg once daily and potentially increasing to 2-3 mg daily 3. For schizophrenia in adults, the recommended target dose is 2-4 mg once daily, while adolescents typically receive 2-4 mg daily based on weight 4. Common side effects include weight gain, akathisia (restlessness), and sedation, and the medication should be titrated slowly to minimize these effects 5. It's worth noting that brexpiprazole has a unique pharmacological profile compared to other antipsychotic agents, with a more tolerable side effect profile with regard to akathisia, extrapyramidal dysfunction, and sedation 2. However, direct head-to-head comparisons with other available agents are needed to fully understand the efficacy and side effect profile of brexpiprazole 2. Overall, brexpiprazole represents a useful treatment option for the treatment of patients with schizophrenia and MDD, with a favorable efficacy and safety profile 4, 3, 2, 5.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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