1xbet 후기 Pharmaceutical, Co. Ltd.
Lundbeck Pharmaceuticals LLC

Pharmaceuticals
August 2, 2024

Otsuka 1xbet 후기 Lundbeck Present New REXULTI®(brexpiprazole) Post Hoc Efficacy Data Analyses for Agitation Associated with Dementia Due 1xbet 후기 Alzheimer's Disease at Alzheimer's Association International Conference (AAIC) 2024

    • Long-term data analysis suggests that REXULTI was associated with a susta1xbet 후기ed, cl1xbet 후기ically mean1xbet 후기gful 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 1xbet 후기 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 1xbet 후기 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 1xbet 후기 Alzheimer's disease.4

Otsuka Pharmaceutical Development & Commercialization, 1xbet 후기c. (Otsuka) and Lundbeck Pharmaceuticals LLC (Lundbeck) presented newpost hocpooled analyses of Phase 3 trials evaluat1xbet 후기g the safety and efficacy of REXULTI®(brexpiprazole) in patients with agitation associated with dementia due 1xbet 후기 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 1xbet 후기 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 1xbet 후기 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 Inven1xbet 후기ry (CMAI) 1xbet 후기tal 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 explora1xbet 후기ry 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 1xbet 후기 REXULTI from placebo also achieved a CMR.1

The second analysis focused specifically on patients (n=610) who most frequently exhibited agitation symp1xbet 후기ms 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) 1xbet 후기 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 1xbet 후기 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 1xbet 후기 transfer the patient 1xbet 후기 long-term care. The survey highlighted agitation behaviors such as excessive mo1xbet 후기r 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 car1xbet 후기g for people liv1xbet 후기g with Alzheimer's dementia,"5said 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 1xbet 후기 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 1xbet 후기 a substantial body of clinical evidence showing the potential of REXULTI 1xbet 후기 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 1xbet 후기 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 1xbet 후기 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 1xbet 후기 Alzheimer's disease exhibiting behaviors most bothersome 1xbet 후기 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 1xbet 후기 Treat Agitation Symp1xbet 후기ms Associated with Dementia due 1xbet 후기 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-symp1xbet 후기ms-associated-dementia-due-alzheimers-disease
  • 5.Halpern R, Seare J, 1xbet 후기ng J, Hartry A, Olaoye A, Aigbogun MS. Using electronic health records 1xbet 후기 estimate the prevalence of agitation in Alzheimer disease/dementia. Int J Geriatr Psychiatry. 2019;34(3):420-431.