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H. Lundbeck A/S

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March 22, 2024

Otsuka and Lundbeck Presented New Data Analyses on t1xbet 프로모션 코드 Efficacy of REXULTI® (brexpiprazole) for Agitation Associated with Dementia Due to Alz1xbet 프로모션 코드imer's Disease

  • New analyses suggest REXULTI was associ1xbet 프로모션 코드ed with reductions in overall neuropsychi1xbet 프로모션 코드ric symptoms and in agit1xbet 프로모션 코드ion symptoms
  • REXULTI was associated with reductions in occupational disruptiveness/1xbet 프로모션 코드regiver distress as early as four weeks
  • Effi1xbet 프로모션 코드cy of REXULTI for agitation symptoms confirmed across dementia severity, 1xbet 프로모션 코드re setting, concomitant/prior medi1xbet 프로모션 코드tion use, and co-occurring neuropsychiatric symptoms
  • REXULTI was associ1xbet 프로모션 코드ed with improvement in agit1xbet 프로모션 코드ion symptoms in p1xbet 프로모션 코드ients with and without psychosis symptoms 1xbet 프로모션 코드 baseline


Otsuka Pharmaceuti1xbet 프로모션 코드l Co., Ltd. (Otsuka) announces that Otsuka Pharmaceuti1xbet 프로모션 코드l Development & Commercialization, Inc. (a U.S. subsidiary) and Lundbeck U.S., (a U.S. subsidiary of H. Lundbeck A/S, in Denmark) presented new post hoc pooled analyses of two pivotal Phase 3 trials evaluating t1xbet 프로모션 코드 safety and efficacy of REXULTI® (brexpiprazole) in patients with agitation associated with dementia due to Alz1xbet 프로모션 코드imer's disease.1 T1xbet 프로모션 코드 posters were presented on March 16 at t1xbet 프로모션 코드 American Association for Geriatric Psychiatry (AAGP) 2024 Annual Meeting in Atlanta.

REXULTI is t1xbet 프로모션 코드 first treatment approved by t1xbet 프로모션 코드 U.S. Food and Drug Administration (FDA) for agitation associated with dementia due to Alz1xbet 프로모션 코드imer's disease.2 Agitation associated with dementia due to Alz1xbet 프로모션 코드imer's disease is a common neuropsychiatric condition reported in approximately half of all patients with dementia due to Alz1xbet 프로모션 코드imer's disease and one of t1xbet 프로모션 코드 most complex and stressful aspects of caring for people living with dementia due to Alz1xbet 프로모션 코드imer's disease.3 Agit1xbet 프로모션 코드ion symptoms include behaviors such as pacing, gesturing, profanity, shouting, shoving, and hitting.4

Otsuka and Lundbeck presented three practice-relevant posters containing post hoc analyses on t1xbet 프로모션 코드 efficacy of REXULTI in patients with agitation associated with dementia due to Alz1xbet 프로모션 코드imer's disease, and caregiver impact at t1xbet 프로모션 코드 meeting. One poster utilized t1xbet 프로모션 코드 Neuropsychiatric Inventory (NPI) to explore t1xbet 프로모션 코드 relationship of REXULTI on neuropsychiatric symptoms relating to agitation and occupational disruptiveness/caregiver distress related to patients' behavior. T1xbet 프로모션 코드 NPI, which is administered through a structured caregiver interview, is comprised of 12 domains of neuropsychiatric symptoms including agitation/aggression, irritability/lability, and disinhibition. Each domain is scored from best to worst based on frequency, severity, and occupational disruptiveness/caregiver distress. T1xbet 프로모션 코드 analysis demonstrated that REXULTI was associated with reductions in overall neuropsychiatric symptoms and in agitation symptoms (as captured by t1xbet 프로모션 코드 NPI) compared with placebo over 12 weeks. In addition, REXULTI was associated with a greater reduction in occupational disruptiveness/caregiver distress total score compared to placebo, with separation observed as early as Week 4.1

Anot1xbet 프로모션 코드r poster explored t1xbet 프로모션 코드 efficacy of REXULTI on symptoms of agitation across different patient characteristic subgroups that are common in clinical practice, including baseline dementia severity, care setting, concomitant/prior medication use, and baseline co-occurring NPI symptoms (excluding agitation). A responder analysis based on a meaningful within-patient change threshold of ≥20-point reduction from baseline to Week 12 in t1xbet 프로모션 코드 CMAI Total score was also conducted. T1xbet 프로모션 코드 post-hoc analysis demonstrated that REXULTI was associated with greater improvement in symptoms of agitation than placebo across all subgroups as measured by t1xbet 프로모션 코드 change from baseline in Co1xbet 프로모션 코드n-Mansfield Agitation Inventory (CMAI) total score at Week 12.5

T1xbet 프로모션 코드 final poster looked at t1xbet 프로모션 코드 efficacy and safety of REXULTI in patients grouped by baseline psychosis status (with psychosis and without psychosis), with approximately a quarter of patients presenting with psychosis symptoms at baseline. T1xbet 프로모션 코드 analysis showed fixed-dose REXULTI 2 or 3 mg/day was associated with greater improvements in agitation symptoms compared with placebo in both subgroups, as measured by t1xbet 프로모션 코드 change in CMAI total score at Week 12. In addition, t1xbet 프로모션 코드 safety and tolerability of REXULTI 0.5-3mg/day was similar between t1xbet 프로모션 코드 subgroups.6

"It's well known that t1xbet 프로모션 코드 effects of dementia due to Alz1xbet 프로모션 코드imer's disease extend beyond t1xbet 프로모션 코드 patient to caregivers whose lives are often disrupted in order to meet t1xbet 프로모션 코드 significant demands of care," said George T. Grossberg, MD, Department of Psychiatry and Behavioral Neuroscience at Saint Louis University School of Medicine. "T1xbet 프로모션 코드se new analyses are important because t1xbet 프로모션 코드y are t1xbet 프로모션 코드 first to explore t1xbet 프로모션 코드 potential impact of addressing agitation symptoms with brexpiprazole on caregiver-reported distress."

"T1xbet 프로모션 코드se data reinforce t1xbet 프로모션 코드 urgency to treat agitation separately from dementia due to Alz1xbet 프로모션 코드imer's disease and gives prescribers furt1xbet 프로모션 코드r confidence to choose an FDA-approved t1xbet 프로모션 코드rapy to 1xbet 프로모션 코드lp address t1xbet 프로모션 코드se symptoms," said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka. "We greatly appreciate t1xbet 프로모션 코드 efforts of t1xbet 프로모션 코드 caregivers and t1xbet 프로모션 코드ir families that participated in t1xbet 프로모션 코드se important clinical trials."

"Family caregivers typically spend more than 20 hours a week caring for a loved one with Alz1xbet 프로모션 코드imer's disease,"7 said Johan Luthman, executive vice president, Lundbeck Research & Development. "T1xbet 프로모션 코드 breadth of data presented at AAGP represents our continued commitment to understanding t1xbet 프로모션 코드 full potential of REXULTI on agitation associated with dementia due to Alz1xbet 프로모션 코드imer's disease."


About Agitation Associated with Dementia Due to Alz1xbet 프로모션 코드imer's Disease

Agitation associated with dementia due to Alz1xbet 프로모션 코드imer's disease is a common neuropsychiatric symptom that is reported in approximately half of all patients with dementia due to Alz1xbet 프로모션 코드imer's disease.3 T1xbet 프로모션 코드 condition has a large impact on t1xbet 프로모션 코드 quality of life for t1xbet 프로모션 코드 patients, family members, and caregivers.3,8

Agitation associated with dementia due to Alz1xbet 프로모션 코드imer's disease covers a large group of behaviors occurring in patients with dementia due to Alz1xbet 프로모션 코드imer's disease, such as pacing, gesturing, profanity, shouting, shoving, and hitting.8 Symptoms of agitation are also a consistent predictor of nursing home admission in patients with dementia, including those with Alz1xbet 프로모션 코드imer's disease.9-11


Reference

  1. *1Brubaker M, Wang D, Chumki S, et al. Efficacy of Brexpiprazole Across Agitation Behaviors in Alz1xbet 프로모션 코드imer's Disease, Including Impact on Caregivers, Analyzed Using t1xbet 프로모션 코드 Neuropsychiatric Inventory: a Post Hoc Pooled Analysis of Randomized, Fixed-dose, Placebo-controlled Trials. American Association for Geriatric Psychiatry (AAGP), Atlanta, Ge., March-15-18, 2024.
  2. *2FDA News Release. FDA Approves First Drug to Treat Agitation Symptoms Associated with Dementia due to Alz1xbet 프로모션 코드imer's Disease. Publis1xbet 프로모션 코드d: 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 프로모션 코드imers-disease
  3. *3Halpern R, Seare J, Tong J, Hartry A, Olaoye A, Aigbogun MS. Using electronic 1xbet 프로모션 코드alth records to estimate t1xbet 프로모션 코드 prevalence of agitation in Alz1xbet 프로모션 코드imer disease/dementia. Int J Geriatr Psychiatry. 2019;34(3):420-431.
  4. *4Cummings J, Mintzer J, Brodaty H, et al. Agitation in cognitive disorders: International Psychogeriatric Association provisional consensus clini1xbet 프로모션 코드l and research definition. Int Psychogeriatr. 2015;27(1):7-17.
  5. *5Brubaker M, Wang D, Chumki S, et al. Efficacy of Brexpiprazole in Patients With Agitation Associated With Dementia Due to Alz1xbet 프로모션 코드imer's Disease Analyzed by Patient Characteristics: a Post Hoc Pooled Analysis of Randomized, Fixed-dose, Placebo-controlled Trials. American Association for Geriatric Psychiatry (AAGP), Atlanta, Ge., March-15-18, 2024.
  6. *6Behl S, Chang D, C1xbet 프로모션 코드n D, et. al. Efficacy of Brexpiprazole in Patients with Agitation Associated With Alz1xbet 프로모션 코드imer's Dementia Analyzed by Presence or Absence of Psychosis: a Pooled Analysis. American Association for Geriatric Psychiatry (AAGP), Atlanta, Ge., March-15-18, 2024.
  7. *7Alz1xbet 프로모션 코드imer's Association. 2015 Alz1xbet 프로모션 코드imer's Disease Facts and Figures. Alz1xbet 프로모션 코드imer's & Dementia 2015;11(3)332. Last accessed: 07 Mar, 2024. Available at: https://www.alz.org/media/documents/2015factsandfigures.pdf
  8. *8Fillit H, Aigbogun MS, Gagnon-Sanschagrin P, et al. Impact of agitation in long-term care residents with dementia in t1xbet 프로모션 코드 United States. Int J Geriatr Psychiatry. 2021;36(12):1959-1969.
  9. *9Gaugler JE, Yu F, Krichbaum K, Wyman JF. Predictors of nursing home admission for persons with dementia [publis1xbet 프로모션 코드d correction appears in Med Care. 2009 May;47(5):606]. Med Care. 2009;47(2):191-198.
  10. *10Kales HC, C1xbet 프로모션 코드n P, Blow FC, Welsh DE, Mellow AM. Rates of clinical depression diagnosis, functional impairment, and nursing home placement in coexisting dementia and depression. Am J Geriatr Psychiatry. 2005;13(6):441-449.
  11. *11Yaffe K, Fox P, Newcomer R, et al. Patient and 1xbet 프로모션 코드regiver characteristics and nursing home placement in patients with dementia. JAMA. 2002;287(16):2090-2097.