Share this to:

Support & Insight for the Autumn of Life

FDA Okays Rexulti for Agitation in Alzheimer’s

The US Food and Drug Administration has announced the supplemental approval of Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer’s. Learn more.
old people's home, dementia

On May 11, 2023, the US Food and Drug Administration announced the supplemental approval of Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer’s, the first FDA-approved treatment option for this indication.

“Agitation is one of the most common and challenging aspects of care among patients with dementia due to Alzheimer’s disease. ‘Agitation’ can include symptoms ranging from pacing or restlessness to verbal and physical aggression,” said Tiffany Farchione, M.D., director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research.

“These symptoms are leading causes of assisted living or nursing home placement and have been associated with accelerated disease progression.”

Dementia is a serious and debilitating neurological condition characterized by progressive decline in one or more cognitive domains in the brain. Dementia can seriously impair an individual’s ability to function independently. Many people living with dementia require permanent at-home or residential care. Alzheimer’s disease, the most common cause of dementia, is an irreversible, progressive brain disorder affecting more than 6.5 million Americans.

Patients with dementia often have behavioral and psychological disturbances. Agitation is among the most persistent, complex, stressful, and costly aspects of care among patients with behavioral and psychological symptoms of dementia.

Two studies

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. In these studies, patients were required to have a probable diagnosis of Alzheimer’s dementia; have a score between 5 to 22 on the Mini-Mental State Examination, a test that detects whether a person is experiencing cognitive impairment; and exhibit the type, frequency, and severity of agitation behaviors that require medication. Trial participants ranged between 51 to 90 years of age. 

In the first study patients received 1 or 2 milligrams (mg) of Rexulti; in the second study patients received 2 or 3 mg of Rexulti.

The primary efficacy endpoint in these two studies was the change from baseline in the Cohen-Mansfield Agitation Inventory total (CMAI) score at week 12. CMAI is a survey tool that uses input from caregivers to rate the frequency of certain agitative behaviors in dementia patients on a scale from 1 to 7. In both studies, patients who received 2 mg or 3 mg of Rexulti showed statistically significant and clinically meaningful improvements in total CMAI scores compared to patients in the placebo group at week 12.

Dosing and Side Effects

The recommended starting dosage for the treatment of agitation associated with dementia due to Alzheimer’s disease is 0.5 mg taken once daily on days 1 to 7. Patients should increase the dosage on days 8 through 14 to 1 mg once daily, and on day 15 to 2 mg once daily. The recommended target dose is 2 mg once daily.

The dosage can be increased to the maximum recommended daily dosage of 3 mg once daily after at least 14 days, based on clinical response and tolerability.

The most common side effects among patients with agitation associated with dementia due to Alzheimer’s disease include headache, dizziness, urinary tract infection, nasopharyngitis, and sleep disturbances (both somnolence and insomnia).

Rexulti will retain the Boxed Warning for medications in this class that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

Fast Track Designation

The FDA granted this application Fast Track designation. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.

The supplemental approval of Rexulti was granted to Otsuka Pharmaceutical Company Ltd., and Lundbeck Inc.


US Food and Drug Administration

Notify of

Inline Feedbacks
View all comments
Hanna Levi Julian

Hanna Levi Julian

Visit Our Pages On:


This site was inspired by my Mom’s autoimmune dementia.

It is a place where we separate out the wheat from the chaffe, the important articles & videos from each week’s river of news. With a new post on Alzheimer’s or dementia appearing on the internet every 7 minutes, the site’s focus on the best information has been a help to many over the past 15 years. Thanks to our many subscribers for your supportive feedback.

The site is dedicated to all those preserving the dignity of the community of people living with dementia.

Peter Berger, Editor


pillows, sheets, full hd wallpaper
Alzheimer's Lethargy Due to Neurodegeneration, Not Insomnia
The tendency of Alzheimer's patients to sleep throughout the day is not due to nighttime insomnia -- it has to do wit...
keto, diet, fat
Ketosis and Alzheimer's: Dr. Cunnane's Dietary Journey
Early evidence indicates that ketogenic therapy is a safe and effective treatment for Alzheimer’s Disease and other f...
FDA-Approved Sargramostim Improves Alzheimer's Cognition
FDA-approved Sargramostim, a normal human protein, improved memory and cognition in Alzheimer's patients in a Phase I...
Would love your thoughts, please comment.x
News, Treatments, Care Tips

Subscribe To The Weekly Newsletter

videos & articles on Research & Prevention
News to Get at the Truth

Subscribe To Our Weekly Newsletter