Otsuka to terminate development of AVP 786 as a potential treatment for agitation associated with dementia due to Alzheimer's disease.
Otsuka Pharmaceutical Co., Ltd. and its U.S. subsidiary, Otsuka Pharmaceutical Development & Commercialization, Inc. announce termination of development of the novel compound AVP 786, which was in development as a potential treatment for patients with agitation associated with dementia due to Alzheimer's disease
Otsuka initiated Phase III trials for AVP 786. In the top-line results of the Phase III trial NCT03393520 (#305 trial) that Otsuka announced in February this year, no statistically significant difference was observed between AVP 786 and placebo in the primary endpoint—average change from baseline to week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) total score. After a detailed analysis of results from the completed trial, Otsuka and OPDC have decided to terminate the development of this drug candidate.
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