Otsuka Terminates Development of Potential Agitation Treatment for Alzheimer Disease

Otsuka Pharmaceutical (Tokyo, Japan) has terminated the development of AVP-786, a potential treatment for agitation associated with Alzheimer disease, after the drug failed to meet its primary endpoint in a phase 3 clinical trial (NCT03393520). The trial evaluated the efficacy of AVP-786 compared to placebo in reducing agitation symptoms measured by the Cohen-Mansfield Agitation Inventory (CMAI) total score over 12 weeks. Top-line results showed no statistically significant difference between AVP-786 and placebo in the primary endpoint of mean change from baseline in CMAI score.

According to company statements, Otsuka plans to analyze the full data set from the phase 3 trial to determine the future potential of AVP-786 in this indication. AVP-786 is a deuterated form of two dextromethorphan/quinidine.