Rexulti (brexpiprazole) is filed in Japan for Alzheimer’s associated agitation – Otsuka

Otsuka Pharmaceutical has filed its antipsychotic agent Rexulti (brexpiprazole) in Japan for a label expansion into agitation associated with dementia due to Alzheimer’s disease. If approved, it would be the first drug to receive this indication in the country.

A domestic PIII clinical trial looked into the safety and efficacy of Rexulti (1 mg/day and 2 mg/day) against placebo over 10 weeks in 410 patients aged 55-90 with Alzheimer’s-associated agitation. Both groups that received Rexulti showed statistically significant improvements compared to placebo in the Cohen-Mansfield Agitation Inventory (CMAI) total score, the primary endpoint. The CMAI is a measure to assess the frequency of 29 agitation symptoms including aggressive and non-aggressive behaviors on a seven-point scale.

Agitation associated with Alzheimer’s, which is observed in around half of people with Alzheimer’s, increases the burdens of caregivers and reduces the quality of life of patients and those around them.