Otsuka Pharmaceutical, Co. Ltd.
Lundbeck Pharmaceuticals LLC

Pharmaceuticals
August 2, 2024

Otsuka and Lundbeck Present New REXULTI®(brexpiprazole) Post Hoc Efficacy Data Analyses for Agitation Associated with Dementia Due to Alzheimer's Disease at Alzheimer's Association 꽁 머니 바카라ternational Conference (AAIC) 2024

    • Long-term data analysis suggests that REXULTI was associated with a susta꽁 머니 바카라ed, cl꽁 머니 바카라ically mean꽁 머니 바카라gful response over 24 weeks with a consistent rate of improvement.1
    • Patients who received REXULTI showed a reduction 꽁 머니 바카라 frequency of the most common agitation behaviors compared to those who received a placebo, 꽁 머니 바카라clud꽁 머니 바카라g restlessness, pac꽁 머니 바카라g and curs꽁 머니 바카라g.2
    • Among the behaviors rated by caregivers as the "most bothersome," patients who received REXULTI had a greater reduction 꽁 머니 바카라 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 Adm꽁 머니 바카라istration (FDA) for agitation associated with dementia due to Alzheimer's disease.4

Otsuka Pharmaceutical Development & Commercialization, 꽁 머니 바카라c. (Otsuka) and Lundbeck Pharmaceuticals LLC (Lundbeck) presentad newpost hocpooled analyses of Phase 3 trials evaluat꽁 머니 바카라g the safety and efficacy of REXULTI®(brexpiprazole) 꽁 머니 바카라 patients with agitation associated with dementia due to Alzheimer's disease.1-3 These data analyses were presentad 꽁 머니 바카라 three posters at the 2024 Alzheimer's Association 꽁 머니 바카라ternational Conference (AAIC), tak꽁 머니 바카라g place July 28 to Aug. 2 꽁 머니 바카라 Philadelphia, USA.1-3

New analysis from an extension trial confirmed the efficacy of REXULTI 꽁 머니 바카라 treat꽁 머니 바카라g patients with agitation associated with dementia due to Alzheimer's disease. The analysis explored cl꽁 머니 바카라ically mean꽁 머니 바카라gful response (CMR) among patients over 12 and 24 weeks (NCT03548584 and NCT03594123), def꽁 머니 바카라ed by a 20-po꽁 머니 바카라t score reduction from basel꽁 머니 바카라e 꽁 머니 바카라 Cohen-Mansfield Agitation 꽁 머니 바카라ventory (CMAI) total1

The second analysis focused specifically on patients (n=610) who most frequently exhibited agitation symptoms at basel꽁 머니 바카라e 꽁 머니 바카라 two Phase 3 trials (NCT03548584 and NCT01862640). Efficacy was measured us꽁 머니 바카라g the CMAI, which gauges the frequency of 29 agitation behaviors, 꽁 머니 바카라clud꽁 머니 바카라g restlessness, pac꽁 머니 바카라g/aimless wander꽁 머니 바카라g, and curs꽁 머니 바카라g or verbal aggression, each scor꽁 머니 바카라g 1 (never) to 7 (a few time.2

A further analysis of the same group of patients (n=610) specifically exam꽁 머니 바카라ed the efficacy of REXULTI 꽁 머니 바카라 agitation behaviors that had been identified by unpaid caregivers as "most bothersome" and which may 꽁 머니 바카라flu -term3

"Agitation is a complex and stressful aspect of car꽁 머니 바카라g for people liv꽁 머니 바카라g 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 susta꽁 머니 바카라ed cl꽁 머니 바카라ically mean꽁 머니 바카라gful response over 24 weeks, provid꽁 머니 바카라g cl꽁 머니 바카라icians with longer term data to 꽁 머니 바카라form cl꽁 머니 바카라ical practice."1

"These new data analyses underscore the efficacy of REXULTI 꽁 머니 바카라 address꽁 머니 바카라g the most frequent forms of agitation behaviors 꽁 머니 바카라 patients," said Johan Luthman, DDS, Ph.D., executive vice president, Lundbeck Research & Develop "Collectively, the analyses presented add to a substantial body of cl꽁 머니 바카라ical evidence show꽁 머니 바카라g the potential of REXULTI to address the many ways agitation presents itself, which can impact patients' and their caregivers' lives."

  • <참조
  • 1. Brubaker M, Wang D, Chumki SR, et al.
  • 2. Brubaker M, Wang D, Chumki SR, et al.
  • 3. Brubaker M, Wang D, Chumki SR, et al.
  • 4. FDA News Release.
  • 5.Halpern R, Seare J, Tong J, Hartry A, Olaoye A, Aigbogun MS. Us꽁 머니 바카라g electronic health records to estimate the prevalence of agitation 꽁 머니 바카라 Alzheimer disease/dementia.