Otsuka to stops development of Alzheimer’s candidate AVP-786

Japanese drugmaker Otsuka Pharmaceutical (TYO: 4768) and its US subsidiary have decided to terminate the development of the novel compound AVP-786, which was being studied 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 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. The drug also failed in a previous Phase III trial for the treatment of moderate-to-severe agitation in patients with Alzheimer's dementia.

Otsuka now says that, after a detailed analysis of results from the completed trial, it has decided to terminate the development of this drug candidate.