18 May 2023 • The Food and Drug Administration has granted Rexulti (Brexpiprazole) oral tablets supplementary approval for the treatment of agitation associated with dementia caused by Alzheimer's disease. This is the first therapy option for this indication that has been approved by the FDA.

"Agitation is one of the most common and difficult aspects of care for patients with Alzheimer's disease dementia. Agitation can include symptoms ranging from pacing or restlessness to verbal and physical aggression," stated Tiffany Farchione, M.D., head of the FDA's Center for Drug Evaluation and Research's Division of Psychiatry.

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 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.

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.

Source: U.S. Food & Drug Administration | Read full sotry