Otsuka tees up Japanese filing for brexpiprazole in Alzheimer's agitation

Japanese drugmaker Otsuka Pharmaceutical (TYO: 4578) has announced positive results from a Phase III trial in its home country for brexpiprazole in the treatment of agitation associated with Alzheimer's dementia.

This trial was designed to assess the efficacy, safety and tolerability of once daily fixed-dose of brexpiprazole. It was a 10-week, multicenter, randomized, double-blind, placebo-controlled study that comprised 410 patients, aged 55 to 90 years, with agitation associated with Alzheimer's dementia. The primary endpoint was mean change from the baseline in the Cohen-Mansfield agitation inventory (CMAI) total score at week 10.

The study’s primary endpoint was attained, demonstrating a statistically-significant improvement in the CMAI total score of the groups administered brexpiprazole 1mg each day or 2mg daily.