Brexpiprazole Approved by FDA To Treat Agitation Associated with Dementia Related to Alzheimer Disease
Brexpiprazole (Rexulti; Otsuka, Princeton, NJ; and Lundbeck LLC, Deerfield, IL), which is currently indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder in adults and for the treatment of schizophrenia in adult and pediatric patients aged 13 y and older, received approval by the Food and Drug Administration (FDA) to treat agitation associated with dementia related to Alzheimer disease (AD). This approval represents the first pharmacologic treatment approved for agitation in this population, although it’s important to note that brexpiprazole is not indicated as an as needed (“prn”) treatment. Estimates suggest that up to 50% of individuals diagnosed with AD experience agitation, which is characterized by aggressive behaviors, physically nonaggressive behaviors, verbally agitated behaviors, and/or hiding and hoarding.
Approval of the supplemental new drug application (sNDA) was based on results from 2 phase 3 clinical trials which found that individuals with agitation associated with dementia related to AD treated with brexpiprazole experienced a 31% greater reduction from baseline in frequency of agitation symptoms compared with those taking a placebo. Agitation frequency and symptoms were measured using the Cohen-Mansfield Agitation Inventory (CMAI).
According to Deborah Dunsire, CEO and President, Lundbeck, “This approval is a testament to our commitment and unwavering support of patients and caregivers to lessen the symptoms of agitation associated with dementia due to Alzheimer’s disease. We look forward to offering this first FDA-approved treatment option to address this significant unmet need for patients. We are grateful to the patients and caregivers who participated in these important trials.”
Important safety information associated with brexpiprazole treatment includes a black box warning of the increased risk of death in elderly people with dementia-related psychosis and an increased risk of suicidal thoughts and actions. Additional serious side effects noted including cerebrovascular problems, neuroleptic malignant syndrome, tardive dyskinesia, and metabolic problems such as hyperglycemia, diabetes, and dyslipidemia.