FDA Approves Otsuka Pharma's Alzheimer's Agitation Drug
The FDA has approved Rexulti (brexpiprazole) oral tablets as the first treatment option for agitation associated with dementia due to Alzheimer's disease. Dementia is a serious and debilitating neurological condition characterized by progressive decline in one or more cognitive domains in the brain. Alzheimer's disease is the most common cause of dementia. The effectiveness of Rexulti for the treatment of agitation associated with dementia due to Alzheimer's disease was determined through two 12-week, randomized, double-blind, placebo-controlled, fixed-dose studies.