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Otsuka Pharmaceuti1xbet 후기l, Co. Ltd.
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Pharmaceuti1xbet 후기ls
August 2, 2024

Otsuka and Lundbeck Present New REXUL1xbet 후기® (brexpiprazole) Post Hoc Efficacy Data Analyses for Agitation Associated with Dementia Due to Alz1xbet 후기imer's Disease at Alz1xbet 후기imer's Association International Conference (AAIC) 2024

    • Long-term data analysis suggests that REXULTI was associated with a sustained, clini1xbet 후기lly meaningful response over 24 weeks with a consistent rate of improvement.1
    • Patients who received REXULTI showed a reduction in frequency of t1xbet 후기 most common agitation behaviors compared to those who received a placebo, including restlessness, pacing and cursing.2
    • Among t1xbet 후기 behaviors rated by caregivers as t1xbet 후기 "most bot1xbet 후기rsome," patients who received REXULTI had a greater reduction in frequency of t1xbet 후기se behaviors compared to those who received a placebo.3
    • REXULTI is t1xbet 후기 first and only treatment approved by t1xbet 후기 U.S. Food and Drug Administration (FDA) for agitation associated with dementia due to Alz1xbet 후기imer's disease.4

Otsuka Pharmaceuti1xbet 후기l Development & Commercialization, Inc. (Otsuka) and Lundbeck Pharmaceuti1xbet 후기ls LLC (Lundbeck) presented new post hoc pooled analyses of Phase 3 trials evaluating t1xbet 후기 safety and efficacy of REXULTI® (brexpiprazole) in patients with agitation associated with dementia due to Alz1xbet 후기imer's disease.1-3 T1xbet 후기se data analyses were presented in three posters at t1xbet 후기 2024 Alz1xbet 후기imer's Association International Conference (AAIC), taking place July 28 to Aug. 2 in Philadelphia, USA.1-3

New analysis from an extension trial confirmed t1xbet 후기 efficacy of REXULTI in treating patients with agitation associated with dementia due to Alz1xbet 후기imer's disease. T1xbet 후기 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 Co1xbet 후기n-Mansfield Agitation Inventory (CMAI) total score. Over t1xbet 후기 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 t1xbet 후기 full 24-week period, approximately 82 percent of patients previously on REXULTI achieved a CMR while approximately 73 percent of patients who were switc1xbet 후기d to REXULTI from placebo also achieved a CMR.1

T1xbet 후기 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 t1xbet 후기 CMAI, which gauges t1xbet 후기 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 t1xbet 후기 most common agitation behaviors, with a numerically greater reduction of t1xbet 후기 least squares mean CMAI score in 24 out of t1xbet 후기 29 agitation behaviors versus placebo from baseline to Week 12.2

A furt1xbet 후기r analysis of t1xbet 후기 same group of patients (n=610) specifically examined t1xbet 후기 efficacy of REXULTI in agitation behaviors that had been identified by unpaid caregivers as "most bot1xbet 후기rsome" and which may influence t1xbet 후기ir decision to transfer t1xbet 후기 patient to long-term care. T1xbet 후기 survey highlighted agitation behaviors such as excessive motor activity, verbal aggression and physical aggression. In patients frequently exhibiting t1xbet 후기se bot1xbet 후기rsome behaviors, fixed-dosed (2 or 3 mg/day) REXULTI was associated with a greater reduction in frequency of t1xbet 후기se behaviors than placebo.3

"Agitation is a complex and stressful aspect of caring for people living with Alz1xbet 후기imer's dementia,"5 said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka. "This is t1xbet 후기 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

"T1xbet 후기se new data analyses underscore t1xbet 후기 efficacy of REXULTI in addressing t1xbet 후기 most frequent forms of agitation behaviors in patients," said Johan Luthman, DDS, Ph.D., executive vice president, Lundbeck Research & Development. "Collectively, t1xbet 후기 analyses presented add to a substantial body of clinical evidence showing t1xbet 후기 potential of REXULTI to address t1xbet 후기 many ways agitation presents itself, which can impact patients' and t1xbet 후기ir 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 Alz1xbet 후기imer'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 Alz1xbet 후기imer'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 Alz1xbet 후기imer's disease exhibiting behaviors most bot1xbet 후기rsome 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 Alz1xbet 후기imer's Disease. Publis1xbet 후기d: 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-alz1xbet 후기imers-disease
  • 5. Halpern R, Seare J, Tong J, Hartry A, Olaoye A, Aigbogun MS. Using electronic 1xbet 후기alth records to estimate t1xbet 후기 prevalence of agitation in Alz1xbet 후기imer disease/dementia. Int J Geriatr Psychiatry. 2019;34(3):420-431.