The FDA approved the first drug that treats agitation associated with Alzheimer's disease.
Rexulti, a brexpiprazole oral tablet, has a recommended starting dosage of 0.5 mg once daily for seven days, which increases steadily to 2 milligrams after 15 days, according to a May 10 agency news release. The FDA granted fast-track designation for the drug.
"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," Tiffany Farchione, MD, director of the division of psychiatry in the FDA's Center for Drug Evaluation and Research, said in the release. "These symptoms are leading causes of assisted living or nursing home placement and have been associated with accelerated disease progression."