The Food and Drug Administration (FDA) has approved brexpiprazole (Rexulti) for the treatment of agitation associated with dementia from Alzheimer disease, making it the first approved treatment option for this condition. The approval was granted through the FDA's fast track designation process.

Brexpiprazole is an atypical antipsychotic originally indicated as an adjunct treatment for major depressive disorders and schizophrenia. It should not be used as an "as needed" (PRN) treatment for dementia due to Alzheimer disease or if agitation from Alzheimer's dementia is not present. The drug is administered orally once per day, with or without food.

Dementia is a descriptive term for a loss of cognitive function that can be caused by a number of disorders affecting the brain. Symptoms include memory problems; loss of ability to problem solve; inability to control emotions; personality changes; and behavioral problems, such as agitation, delusions, and hallucinations.1 Alzheimer disease is a degenerative brain disease and the most common form of dementia, accounting for 60% to 80% of cases.2 According to the Alzheimer's Association, some 6.7 million Americans ages 65 and older are living with Alzheimer's dementia.2

The efficacy of brexpiprazole in treating agitation from Alzheimer's dementia was determined in two 12-week, randomized, double-blind, placebo-controlled, fixed-dose studies. One study included 433 patients and the other 345 patients. The primary efficacy end point in both studies was the change from baseline in the Cohen-Mansfield Agitation Inventory total score at week 12. Total scores were improved in both trials in those who received at least 2 mg of brexpiprazole compared with placebo.

Brexpiprazole's boxed warning of an increased risk of death when used in elderly patients has been revised. Previously, the label stated that brexpiprazole was not approved for the treatment of elderly patients with dementia-related psychosis. The current boxed warning states that the drug is not approved for the treatment of such patients with dementia-related psychosis without agitation associated with dementia due to Alzheimer disease.

The most common adverse effects of the drug when used to treat agitation associated with Alzheimer's dementia are nasopharyngitis and dizziness. Other adverse effects are similar to those found when brexpiprazole is used for other approved clinical indications.

Nurses and NPs should use a drug database to prevent drug interactions, as use of cytochrome P-450 (CYP) isoenzyme 3A4 inhibitors and CYP2D6 inhibitors can increase the levels of brexpiprazole. Conversely, CYP3A4 inducers can reduce the available amount of brexpiprazole.

For complete prescribing information for brexpiprazole, go to http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205422s009lbl.pdf.

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