Otsuka Phase III results of AVP-786 in Alzheimer's agitation misses gaol

13 February 2024

Shares of Japanese drugmaker Otsuka Pharmaceutical (TYO: 4768) fell more than 5% to 5,359 yen today, as it released top line results of the Phase III clinical trial of AVP-786 in the treatment of agitation associated with dementia due to Alzheimer's disease.

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.

This is the second setback for AVP-789, which also failed in a previous Phase III trial for the treatment of moderate-to-severe agitation in patients with Alzheimer's dementia.

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