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REXULTI® (brexpiprazole) + antidepressants:
safety profile in 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%
- 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%
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
Two adverse reactions were dose-dependent
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 therapy; 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 for antidepressant treatment + REXULTI vs antidepressant treatment + placebo
Discontinuations due to most common adverse events
Discontinuations due to most common adverse events
REXULTI + antidepressants: metabolic profile in short and long-term trials
METABOLIC CHANGE
Percentage of patients whose values shifted from baseline to post-baseline4,5
Percentage of patients whose values shifted from baseline to post-baseline4,5
bThe REXULTI open-label MDD trials4:
- 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.
The safety population included patients randomized between 1 mg/day and 3 mg/day of ADT + REXULTI.
HDL, high-density lipoprotein; LDL, low-density lipoprotein.
Weight change results across all doses4,6‑9
Weight change results across all doses4,6‑9
bThe REXULTI open-label MDD trials4:
- 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.9
The standard conversion for kilograms (kg) to pounds (lb) is 1 kg for 2.20462 lb.
Important Warning and Precaution for Metabolic Changes
Atypical antipsychotic agents have been associated with metabolic changes that include Hyperglycemia/Diabetes Mellitus, Dyslipidemia, and Weight Gain. Clinical monitoring is recommended.
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