Safety Profile

REXULTI® (brexpiprazole): Demonstrated safety profile

Adverse reactions in 2% of patients treated with REXULTI and greater than placebo from two 12-week pivotal trials across all doses

Adverse reactions safety
REXULTI adverse events chart from trials REXULTI adverse events chart

a1 mg once a day REXULTI dosage is not a recommended dosage for the treatment of agitation associated with dementia due to Alzheimer’s disease.

bDizziness and Vertigo are grouped to Dizziness

cSedation and somnolence are grouped to somnolence.

dInitial insomnia and insomnia are grouped to insomnia

Most common adverse reaction occurring in ≥4% of patients and at least twice the rate of placebo were nasopharyngitis and dizziness.

At a dose 4 times the MRHD for the treatment of agitation associated with dementia due to Alzheimer's disease, REXULTI does not prolong the QTc interval to any clinically relevant extent.

MRHD, Maximum Recommended Human Dose.

REXULTI vs placebo: Similar discontinuation rates due to adverse reactions from two 12-week pivotal trials across all doses

Discontinuation rates charts REXULTI and Placebo on-treatment charts
Discontinuation rates charts REXULTI and Placebo on-treatment charts

REXULTI: Extension study primary objective assessed the long-term safety and tolerability1

Study details1

This extension trial studied REXULTI 2 or 3 mg in a Phase III, 12-week, multicenter, non-pivotal, single-arm trial

  • ​Patients previously randomized to REXULTI continued their previous dose
  • ​Patients previously randomized to placebo were initiated on REXULTI
  • ​Dosing was concealed to maintain blinding of the placebo-controlled trial; dose adjustments were permitted

Study limitations1-3

  • ​The extension study did not include a control group and was a nonrandomized, single-group assignment
  • Sample size was not based on statistical power considerations
  • The trial population was derived from eligible patients who rolled over from Study 7

REXULTI: Long-term extension study design1

  • All patients were on REXULTI at Week 12; there was no placebo treatment arm during the extension study period1

Baseline characteristics1,

*Baseline is the Week 12 visit of the placebo-controlled trial.    
BMI, body mass index; CMAI, Cohen-Mansfield Agitation Inventory; MMSE, Mini-Mental State Examination; SD, standard deviation.

Adverse reactions in 2% of patients treated with REXULTI1

In the 12-week extension study of REXULTI, 1% of patients had EPS-related reported adverse reactions (excluding akathisia), and 0% of patients had akathisia reported.

EPS, extrapyramidal symptoms.

REXULTI: Exploratory analysis of CMAI total score1

Efficacy of REXULTI in the extension study was an exploratory endpoint