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 ADTa + REXULTI (all doses; n=643) vs ADTa + placebo (n=411)

  • Akathisia: 9% vs 2%
  • Headache: 7% vs 6%
  • Weight increase: 7% vs 2%
  • Somnolence: 5% vs 0.5%
  • Nasopharyngitis: 4% vs 2%
  • Tremor: 4% vs 2%
  • Fatigue: 3% vs 2%
  • Increased appetite: 3% vs 2%
  • Anxiety: 3% vs 1%
  • Dizziness: 3% vs 1%
  • Restlessness: 3% vs 0%
  • Blood cortisol decrease: 2% vs 1%
  • Constipation: 2% vs 1%
  • Increased appetite: 3% vs 2%
  • Anxiety: 3% vs 1%
  • Dizziness: 3% vs 1%
  • Restlessness: 3% vs 0%
  • Blood cortisol decrease: 2% vs 1%
  • Constipation: 2% vs 1%
  • 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%, respectively    1

Most common adverse reactions occurred in ≥5% of patients and at least twice the rate of placebo from two 6-week pivotal trials

Most common adverse reactions occurred in ≥5% of patients and at least twice the rate of placebo from two 6-week pivotal trials

Two adverse reactions were dose-dependent

Dose dependent adverse reactions REXULTI vs placebo chart Dose-dependent Adverse Reactions chart

Two adverse reactions were dose-dependent

dose-dependent adverse reactions REXULTI vs placebo chart

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

ADT, antidepressant treatment; MDD, major depressive disorder; SNRI, serotonin and norepinephrine reuptake inhibitor; SSRI, selective serotonin reuptake inhibitor.

 

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

Discontinuation rates for antidepressant
treatment + REXULTI vs antidepressant treatment + placebo

discontinuation rates REXULTI vs placebo diagram Discontinuation Rates diagram ADT + REXULTI (n=643) 3 % ADT + Placebo (n=411) 1 %

Discontinuation rates for antidepressant treatment + REXULTI vs antidepressant treatment + placebo

discontinuation rates REXULTI vs placebo diagram Discontinuation Rates diagram ADT + Placebo (n=411) 1 % ADT + REXULTI (n=643) 3 %

Discontinuations due to most common adverse events

discontinuation rates REXULTI vs placebo chart Discontinuation Rates chart 0 % 0 % 0 . 9 % 0 % Due t o a k athisia 3 Due t o w eight inc r eased 4 A D T + RE X U L TI (all dose s ) (n= 6 43) A D T + Pla c ebo (n= 4 11)

Discontinuations due to most common adverse events

discontinuation rates REXULTI vs placebo chart Discontinuation Rates chart Due to akathisia 3 Due to weight increased 4 ADT + REXULTI (all doses) 0.9 (n=643) ADT + REXULTI (all doses) (n=643) ADT + Placebo (n=411) ADT + Placebo (n=411) % 0 % 0 % 0 %
View dosing information and titration schedule
 

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

METABOLIC CHANGE

Percentage of patients whose values shifted from baseline to post-baseline5,6

Percentage of patients whose values shifted from baseline to post-baseline5,6

percentage of patients whose values shifted from baseline to post-baseline Metabolic Change chart Chole s t e r ol T rigl y c erides F a s ting serum glu c ose % of patients who shi f t ed f r om: 9 % 3 % 14 % 17 % 0 . 2 % 0 . 6 % 9 % A D T + RE X U L TI A D T + Pla c ebo A D T + RE X U L TI 5 2 - w eek, open-label, fl e xible-dose trials b 6 - w eek, pla c ebo- c ont r olled, fi x ed-dose pi v otal trials < 150 m g / dL ≥ 200 t o < 500 m g / dL < 150 m g / dL ≥ 500 m g / dL F a s ting LDL chole s t e r ol < 100 m g / dL ≥ 160 m g / dL F a s ting HDL chole s t e r ol ≥ 40 m g / dL < 40 m g / dL F a s ting t otal chole s t e r ol < 200 m g / dL ≥ 2 40 m g / dL < 150 m g / dL ≥ 150 t o < 200 m g / dL ≥ 500 m g / dL Normal Bo r derline Normal Bo r derline High Normal High Normal V ery High V ery High Normal High Normal High Normal L o w ≥ 1 2 6 m g / dL < 100 m g / dL ≥ 100 t o < 1 2 6 m g / dL 9 % 6 6 % 0 % 5 0 % 5 0 % 0 . 2 % 6

Discontinuation due to weight increase across all doses