REXULTI® (brexpiprazole) demonstrated consistent safety across 2 clinical trials with a combined total of >500 patients aged 51-90 years

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

^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 in the Prescribing Information.
^dInitial insomnia and insomnia are grouped to insomnia.

Most common ARs in ≥4% of patients and at least twice the rate of placebo: nasopharyngitis and dizziness.

Does not prolong QTc interval to any clinically relevant extent at 4x MRHD for the treatment of agitation associated with dementia due to Alzheimer's disease.

AR, adverse reactions; MRHD, maximum recommended human dose; QTc, corrected QT interval.

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

Nervous system disorder discontinuations with REXULTI¹

• ​1 (0.2%) discontinuation for somnolence; 0 discontinuations for sedation
• 1 (0.2%) discontinuation for dizziness; 0 discontinuation for headache

REXULTI: Extension study primary objective assessed the long-term safety and tolerability²

Long-term extension study design²

Study design

• All patients were on REXULTI at Week 12; there was no placebo treatment arm during the extension study period²

Baseline characteristics^2,e

Adverse reactions in ≥2% of patients treated with REXULTI^1,2

• In the 12-week extension study of REXULTI, 1% of patients had EPS-related adverse reactions (excluding akathisia) reported, and 0% of patients had akathisia reported²
• Similar discontinuation rates due to adverse reactions were observed in Study 7 and the 12-week extension trial; twelve patients (4.6%) discontinued due to TEAEs^2,3
• 1 (0.6%) discontinuation to somnolence; 0 discontinuations due to sedation¹

^fSomnolence and sedation are grouped to somnolence adverse reactions in the Prescribing Information.
EPS, extrapyramidal symptoms; TEAE, treatment-emergent adverse event.

Exploratory analysis of CMAI total score²

Efficacy of REXULTI in the extension study was an exploratory endpoint²

Cumulative week.

​An exploratory analysis examined the change from Week 12 to Week 24 in CMAI total score

Mean (SD) CMAI total score continued to improve in the extension trial, from 59.4 (17.7) points at Week 12 to 50.9 (15.0) points at Week 24, a mean (SD) change of -9.1 (13.5) points. Mean (SD) improvement from Week 12 to Week 24 was greater in the prior placebo subgroup (from 63.0 [18.1] to 51.6 [14.4], a change of -12.5 [14.6] points) than in the prior brexpiprazole subgroup (from 57.3 [17.2] to 50.4 [15.4], a change of -7.1 [12.3] points). By Week 24, mean CMAI total scores were similar in both subgroups.²

CMAI, Cohen-Mansfield Agitation Inventory; LS, least squares; SD, standard deviation.

References: 1. Data on file (REX-655). 2. Behl S, Slomkowski M, Chen D, et al. Brexpiprazole for the treatment of agitation associated with dementia due to Alzheimer’s disease: a 12-week, active-treatment, extension trial. J Alzheimers Dis. 2024;102(2):520–529. 3. Lee D, Slomkowski M, Hefting N, et al. Brexpiprazole for the treatment of agitation in Alzheimer dementia: a randomized clinical trial. JAMA Neurol. 2023;80(12):1307-1316.