Demonstrated safety profile for REXULTI® (brexpiprazole) in adults

Study 3 and Study 4: REXULTI—adverse reactions that occurred in ≥2%
of patients and greater incidence vs placebo from two 6-week pivotal trials

• Most common adverse reaction occurring in ≥4% of patients and at least twice the rate of placebo was weight increased
• In both trials, akathisia occurred most often during the first 3 weeks of treatment, and no incidences resulted in treatment discontinuation^1,2
• The safety population included patients receiving 1 mg/day

Additional safety information across 2 pivotal trials

REXULTI—safety considerations evaluated over 6 weeks³

QTc, corrected QT.

REXULTI: Metabolic data across all doses in short- and long-term trials in adults

Important Warning and Precaution for Metabolic Changes

Atypical antipsychotic drugs have been associated with metabolic changes that include Hyperglycemia/Diabetes Mellitus, Dyslipidemia, and Weight Gain. Clinical monitoring is recommended.

Weight change results across all doses^4,5

^aAfter the conclusion of the 6-week trial, patients who elected to remain in the trial, patients from the Phase 2 trial, and de novo patients were treated with flexible doses of REXULTI (1 mg to 6 mg) in a 52-week, open-label trial, and no placebo control was included. Safety data were collected at regular intervals throughout the 52 weeks. The overall N was 813; n values for individual parameters varied.⁶

^bSD for mean weight increased at 6 weeks were 3.4 kg for REXULTI and 2.7 kg for placebo, at 26 weeks was 5.5 kg for REXULTI, and at 52 weeks was 7.3 kg for REXULTI.^6,7

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

SD, standard deviation.

Discontinuation due to weight increased across all doses^6,8

^aAfter the conclusion of the 6-week trial, patients who elected to remain in the trial, patients from the Phase 2 trial, and de novo patients were treated with flexible doses of REXULTI (1 mg to 6 mg) in a 52-week, open-label trial, and no placebo control was included. Safety data were collected at regular intervals throughout the 52 weeks. The overall N was 813; n values for individual parameters varied.⁶

Percentage of patients whose values shifted from baseline to post-baseline^6,9

^aAfter the conclusion of the 6-week trial, patients who elected to remain in the trial, patients from the Phase 2 trial, and de novo patients were treated with flexible doses of REXULTI (1 mg to 6 mg) in a 52-week, open-label trial, and no placebo control was included. Safety data were collected at regular intervals throughout the 52 weeks. The overall N was 813; n values for individual parameters varied.⁶

HDL, high-density lipoprotein; LDL, low-density lipoprotein.