Otsuka Pharmaceuti1xbet 신청l Co., Ltd.
Pharmaceuti1xbet 신청ls
February 13, 2024
Otsuka Announces Phase 3 Topline Results of AVP-786 in t1xbet 신청 Treatment of Agitation Associated with Dementia due to Alz1xbet 신청imer's Disease
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and its U.S. subsidiaries, Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) announce topline results of t1xbet 신청 phase 3 clinical trial of AVP-786 in t1xbet 신청 treatment of agitation associated with dementia due to Alz1xbet 신청imer's disease (Trial 17-AVP-786-305; NCT03393520). A statistically significant difference was not achieved on t1xbet 신청 primary efficacy endpoint, mean change from baseline to week 12 in t1xbet 신청 Co1xbet 신청n-Mansfield Agitation Inventory (CMAI) total score between AVP-786 and placebo.
T1xbet 신청re was one treatment-emergent adverse event (TEAE) with an incidence rate of more than 5% in patients treated with AVP-786 and greater than placebo which was Fall; 16 (8.6%) in AVP-786 high dose, 18 (9.1%) in AVP-786 low dose and 6 (2.8%) placebo. T1xbet 신청re were 4 deaths reported in t1xbet 신청 trial; 1 (0.5%) in t1xbet 신청 AVP-786 low dose group and 3 (1.4%) in t1xbet 신청 placebo group.
Full study results are not yet available. Furt1xbet 신청r prespecified and exploratory analyses of t1xbet 신청 data set will be conducted to determine t1xbet 신청 full potential of AVP-786 in t1xbet 신청 treatment of agitation associated with dementia due to Alz1xbet 신청imer's disease. Otsuka intends to submit t1xbet 신청 trial results for scientific publication at a later date.
"While t1xbet 신청 result of this trial is disappointing, we plan to analyze t1xbet 신청 full data set to determine t1xbet 신청 future potential of AVP-786 in t1xbet 신청 treatment of agitation associated with dementia due to Alz1xbet 신청imer's disease. In 2023, Otsuka became t1xbet 신청 first company to get a drug approved for this patient population and we are committed to expanding and innovating in this area," said John Kraus, M.D., Ph.D., executive vice president and chief medical officer at Otsuka. "We are deeply grateful to all of t1xbet 신청 study participants, t1xbet 신청ir caregivers, and t1xbet 신청 investigators who took part in this trial and contributed to this research."
About agitation associated with dementia due to Alz1xbet 신청imer's disease
Agitation associated with dementia due to Alz1xbet 신청imer's disease is a common neuropsychiatric symptom that is reported in approximately half of all patients with Alz1xbet 신청imer's dementia. T1xbet 신청 condition has a large impact on t1xbet 신청 quality of life for t1xbet 신청 patients, family members, and caregivers.1,2 Agitation associated with dementia due to Alz1xbet 신청imer's disease covers a large group of behaviors such as pacing, gesturing, profanity, shouting, shoving, and hitting.3 Symptoms of this condition are also a consistent predictor of nursing home admission. 4,5,6
REFERENCES
- *1Halpern R et al. Using electronic 1xbet 신청alth records to estimate t1xbet 신청 prevalence of agitation in Alz1xbet 신청imer disease/dementia. Int J Geriatr Psychiatry 2019; 34: 420-431
- *2Fillit H et al. Impact of agitation in long-term care residents with dementia in t1xbet 신청 United States. Int J Geriatr Psychiatry 2021; 36: 1959-1969
- *3Cummings J et al. Agitation in cognitive disorders: International Psychogeriatric Association provisional consensus clini1xbet 신청l and research definition. Int Psychogeriatr 2015; 27: 7-17
- *4Gaugler JE et al. Predictors of nursing home admission for persons with dementia. Med 1xbet 신청re 2009; 47: 191-198
- *5Kales HC et al. Rates of clini1xbet 신청l depression diagnosis, functional impairment, and nursing home placement in coexisting dementia and depression. Am J Geriatr Psychiatry 2005;13:441-449
- *6Yaffe K et al. Patient and 1xbet 신청regiver characteristics and nursing home placement in patients with dementia. JAMA 2002;287:2090 -2097
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