FDA approves first drug for agitation related to Alzheimer’s dementia

Brexpiprazole (Rexulti) is the first treatment to be approved for agitation associated with dementia due to Alzheimer disease. Effectiveness was determined through two 12-week RCTs. The most common adverse effects observed in the trials were headache, dizziness, UTI, nasopharyngitis, and sleep disturbance. Brexpiprazole will retain the Boxed Warning about mortality risk in elderly patients with dementia-related psychosis treated with antipsychotic drugs.