On 22 May, Otsuka Pharmaceutical has announced the termination of development of its compound AVP-786, which was under investigation as a therapy for agitation associated with dementia. The decision follows the recent top-line results of a Phase 3 trial, which evaluated the efficacy, safety and tolerability of AVP-786 for the treatment of agitation in people with dementia of the Alzheimer's type.
The experimental drug failed to meet the primary efficacy endpoint, showing no significant difference from placebo in the change from baseline to week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) total score. The multicenter, randomised, double-blind, placebo-controlled study's top-line results were initially released in February, with Otsuka subsequently conducting a detailed analysis of the data from the completed trial. Following this detailed analysis, the company announced the decision to stop its clinical programme for AVP-786.
As a leading company in the central nervous system field, the company said that it will continue research and development efforts to meet unresolved medical needs and will continue to focus on addressing agitation associated with Alzheimer's disease.
https://www.otsuka.co.jp/en/company/newsreleases/2024/20240522_2.html
