From the FDA Drug Label
The efficacy of brexpiprazole in the adjunctive treatment of major depressive disorder (MDD) was evaluated in two 6-week double-blind, placebo-controlled, fixed-dose studies of adult patients meeting DSM-IV-TR criteria for MDD, with or without symptoms of anxiety, who had an inadequate response to prior antidepressant therapy (1 to 3 courses) in the current episode and who had also demonstrated an inadequate response throughout the 8 weeks of prospective antidepressant treatment (with escitalopram, fluoxetine, paroxetine controlled-release, sertraline, duloxetine delayed-release, or venlafaxine extended-release)
In Studies 1 and 2, brexpiprazole (plus ADT) 2 mg once daily and 3 mg once daily were superior to placebo plus ADT in reducing mean MADRS total scores.
Rexulti as an add-on treatment is supported by the FDA drug label, which states that brexpiprazole (Rexulti) can be used as an adjunctive treatment for major depressive disorder (MDD) in adults who have had an inadequate response to prior antidepressant therapy.
- The recommended dosages for brexpiprazole as an add-on treatment are 2 mg once daily and 3 mg once daily.
- The studies showed that brexpiprazole (plus ADT) 2 mg once daily and 3 mg once daily were superior to placebo plus ADT in reducing mean MADRS total scores 1.
From the Research
Rexulti (brexpiprazole) is a recommended add-on medication for patients with major depressive disorder who have had an inadequate response to antidepressant therapy alone, with a target dose of 2 mg daily. The recommended starting dose is 0.5 mg or 1 mg once daily, typically taken with or without food at the same time each day. The dose can be gradually increased based on clinical response and tolerability. When used as an adjunctive treatment, Rexulti should be added to an existing antidepressant rather than replacing it. Patients should continue both medications as prescribed and not stop either abruptly. Rexulti works as an atypical antipsychotic with partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A receptors, which complements the mechanism of traditional antidepressants.
Key Points
- The efficacy of brexpiprazole as an adjunctive treatment for major depressive disorder has been established in clinical trials, with a number needed to treat (NNT) of 12 2.
- Brexpiprazole has a unique receptor binding profile, with low intrinsic D2 activity, which may result in a lower risk of activation-like adverse effects, such as akathisia, compared to other antipsychotics 3.
- Common side effects of brexpiprazole include weight gain, akathisia (restlessness), and increased appetite, with a number needed to harm (NNH) of 53 for discontinuation due to adverse events 2.
- The long-term efficacy and tolerability of brexpiprazole as an adjunctive treatment for major depressive disorder have been demonstrated in clinical trials, with a weighted average remission proportion of 0.33 4.
- Brexpiprazole has been compared to other antipsychotics, such as aripiprazole, and has been shown to have a similar efficacy profile, but with a potentially lower risk of akathisia and somnolence 5.
Clinical Considerations
- Regular follow-up appointments are important to monitor effectiveness and adjust dosing as needed.
- Patients should be educated on the potential side effects of brexpiprazole and the importance of continuing both medications as prescribed.
- The use of brexpiprazole as an adjunctive treatment for major depressive disorder should be individualized, taking into account the patient's medical history, current medications, and response to treatment.