REXULTI® (brexpiprazole) + antidepressants:
safety profile in adult patients with MDD

Adverse reactions that occurred in ≥2% of patients and with greater incidence

than placebo from two 6-week pivotal trials across all doses

Rates for ADT^a + REXULTI (all doses; n=643) vs ADT^a + placebo (n=411)

The most common adverse reactions (≥5%) and at least twice the rate of placebo for ADT + REXULTI vs ADT + placebo were weight increased (7% vs 2%), somnolence (5% vs 0.5%), and akathisia (9% vs 2%)

• In patients taking ADT + REXULTI (n=643, all doses) vs ADT + placebo (n=411), the incidence of decreased libido was 0.6% vs 0.2%, respectively¹

^aThe antidepressants studied included SSRIs and SNRIs. 
The safety population included patients randomized between 1 mg/day and 3 mg/day of ADT + REXULTI.

REXULTI + antidepressants: few discontinuations due to adverse reactions over 6 weeks across all doses

In patients taking ADT + REXULTI (n=643, all doses) vs ADT + placebo (n=411), the rate of discontinuation due to akathisia was 0.9% vs 0% and the rate of discontinuation due to weight gain was 0% vs 0%, respectively^3,4

REXULTI + antidepressants: metabolic profile in short- and long-term trials

Percentage of patients whose values shifted from baseline to post-baseline

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Discontinuation due to weight increase across all doses

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^bThe REXULTI open-label MDD trials⁶:

• After the conclusion of the 6-week trials, patients who elected to remain in a trial, patients from Phase 2 trials, and de novo patients were treated with flexible doses of antidepressants + REXULTI in a 52-week, open-label trial, where no placebo control was included
• Safety data were collected at regular intervals throughout the 52-week, open-label trial

ADT, antidepressant treatment; HDL, high-density lipoprotein; LDL, low-density lipoprotein; MDD, major depressive disorder; SNRI, serotonin and norepinephrine reuptake inhibitor; SSRI, selective serotonin reuptake inhibitor.

Weight change results across all doses

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^bThe REXULTI open-label MDD trials¹⁰:

• After the conclusion of the 6-week trials, patients who elected to remain in a trial, patients from Phase 2 trials, and de novo patients were treated with flexible doses of antidepressants + REXULTI in a 52-week, open-label trial, where no placebo control was included
• Safety data were collected at regular intervals throughout the 52-week, open-label trial

^cStandard deviation for mean weight increase at 6 weeks was 2.2 kg for REXULTI and 1.7 kg for placebo, at 26 weeks was 4.7 kg for REXULTI, and at 52 weeks was 6.1 kg for REXULTI.¹⁰

The safety population included patients randomized between 1 mg/day and 3 mg/day of ADT + REXULTI.⁶

The standard conversion for kilograms (kg) to pounds (lb) is 1 kg for 2.20462 lb.

ADT, antidepressant treatment; MDD, major depressive disorder.