Phase III topline results of AVP 786 announced for the treatment of agitation associated with dementia due to Alzheimer’s disease.-Otsuka
Otsuka Pharmaceutical Development & Commercialization, Inc., and our parent company Otsuka Pharmaceutical, Co. Ltd. announce topline results of the phase III clinical trial of AVP- 86 in the treatment of agitation associated with dementia due to Alzheimer’s disease (Trial 17-AVP-786-305; NCT03393520).
A statistically significant difference was not achieved on the primary efficacy endpoint, mean change from baseline to week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) total score between AVP 786 and placebo.
There was one treatment-emergent adverse event, a fall, that appeared with an incidence rate of more than 5% in patients treated with AVP 786 and greater than placebo; 16 (8.6%) in AVP 786 high dose, 18 (9.1%) in AV -786 low dose and 6 (2.8%) placebo. There were 4 deaths reported in the trial; 1 (0.5%) in the AVP 786 low dose group and 3 (1.4%) in the placebo group.
Full study results are not yet available. Further prespecified and exploratory analyses of the data set will be conducted to determine the full potential of AVP 786 in the treatment of agitation associated with dementia due to Alzheimer’s disease. Otsuka intends to submit the trial results for scientific publication at a later date.
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