• Long-term data analysis suggests that REXULTI was associated with a sustained, clinically meaningful response over 24 weeks with a consistent rate of improvement.¹
• Patients who received REXULTI showed a reduction in frequency of the most common agitation behaviors compared to those who received a placebo, including restlessness, pacing and cursing.²
• Among the behaviors rated by caregivers as the "most bothersome," patients who received REXULTI had a greater reduction in frequency of these behaviors compared to those who received a placebo.³
• REXULTI is the first and only treatment approved by the U.S. Food and Drug Administration (FDA) for agitation associated with dementia due to Alzheimer's disease.⁴
  

Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) and Lundbeck Pharmaceuticals LLC (Lundbeck) presented new post hoc pooled analyses of Phase 3 trials evaluating the safety and efficacy of REXULTI^® (brexpiprazole) in patients with agitation associated with dementia due to Alzheimer's disease.^1-3 These data analyses were presented in three posters at the 2024 Alzheimer's Association International Conference (AAIC), taking place July 28 to Aug. 2 in Philadelphia, USA.^1-3

New analysis from an extension trial confirmed the efficacy of REXULTI in treating patients with agitation associated with dementia due to Alzheimer's disease. The analysis explored clinically meaningful response (CMR) among patients over 12 and 24 weeks (NCT03548584 and NCT03594123), defined by a 20-point score reduction from baseline in Cohen-Mansfield Agitation Inventory (CMAI) total score. Over the initial 12-week Phase 3 trial period, approximately 62 percent of patients who received REXULTI achieved a CMR versus approximately 45 percent of patients who received placebo. Following this, patients enrolled in a 12-week extension trial, during which efficacy was an exploratory endpoint. Over the full 24-week period, approximately 82 percent of patients previously on REXULTI achieved a CMR while approximately 73 percent of patients who were switched to REXULTI from placebo also achieved a CMR.¹

The second analysis focused specifically on patients (n=610) who most frequently exhibited agitation symptoms at baseline in two Phase 3 trials (NCT03548584 and NCT01862640). Efficacy was measured using the CMAI, which gauges the frequency of 29 agitation behaviors, including restlessness, pacing/aimless wandering, and cursing or verbal aggression, each scoring 1 (never) to 7 (a few times an hour). Patients taking REXULTI showed a reduction in frequency of the most common agitation behaviors, with a numerically greater reduction of the least squares mean CMAI score in 24 out of the 29 agitation behaviors versus placebo from baseline to Week 12.²

A further analysis of the same group of patients (n=610) specifically examined the efficacy of REXULTI in agitation behaviors that had been identified by unpaid caregivers as "most bothersome" and which may influence their decision to transfer the patient to long-term care. The survey highlighted agitation behaviors such as excessive motor activity, verbal aggression and physical aggression. In patients frequently exhibiting these bothersome behaviors, fixed-dosed (2 or 3 mg/day) REXULTI was associated with a greater reduction in frequency of these behaviors than placebo.³

"Agitation is a complex and stressful aspect of caring for people living with Alzheimer's dementia,"⁵ said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka. "This is the first time REXULTI was associated with a sustained clinically meaningful response over 24 weeks, providing clinicians with longer term data to inform clinical practice."¹

"These new data analyses underscore the efficacy of REXULTI in addressing the most frequent forms of agitation behaviors in patients," said Johan Luthman, DDS, Ph.D., executive vice president, Lundbeck Research & Development. "Collectively, the analyses presented add to a substantial body of clinical evidence showing the potential of REXULTI to address the many ways agitation presents itself, which can impact patients' and their caregivers' lives."

• ＜Reference＞
• 1. Brubaker M, Wang D, Chumki SR, et al. Sustained clinically meaningful response in patients with agitation associated with dementia due to Alzheimer's disease treated with brexpiprazole: post hoc analysis. Presented at AAIC (July 28-August 2).
• 2. Brubaker M, Wang D, Chumki SR, et al. Efficacy of brexpiprazole on frequently occurring agitation behaviors in patients with dementia due to Alzheimer's disease: post hoc pooled analysis of two randomized controlled trials. Presented at AAIC (July 28-August 2).
• 3. Brubaker M, Wang D, Chumki SR, et al. Efficacy of brexpiprazole on agitation in patients with dementia due to Alzheimer's disease exhibiting behaviors most bothersome to caregivers: post hoc pooled analysis of two randomized controlled trials. Presented at AAIC (July 28-August 2).
• 4. FDA News Release. FDA Approves First Drug to Treat Agitation Symptoms Associated with Dementia due to Alzheimer's Disease. Published: May 11, 2023. Last accessed: Feb. 20, 2024. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-treat-agitation-symptoms-associated-dementia-due-alzheimers-disease
• 5. Halpern R, Seare J, Tong J, Hartry A, Olaoye A, Aigbogun MS. Using electronic health records to estimate the prevalence of agitation in Alzheimer disease/dementia. Int J Geriatr Psychiatry. 2019;34(3):420-431.