Otsuka Pharmaceutical Co., Ltd. (Otsuka) and its U.S. subsidiary, Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) 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 3 trials for AVP-786. In the top-line results of the Phase 3 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.

As a leading company in the central nervous system field, Otsuka will continue research and development efforts to meet unresolved medical needs and will continue to focus on addressing agitation associated with Alzheimer's disease.