Abstract
The U.S. Food and Drug Administration (FDA) has approved brexpiprazole (Rexulti) for agitation associated with Alzheimer's disease dementia, the agency announced last week, the medical news service MedPage Today reported. The new indication for brexpiprazole will make it the first FDA‐approved treatment for this condition. The atypical antipsychotic was previously approved for treating major depressive disorder and schizophrenia. “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, in a press release. “These symptoms are leading causes of assisted living or nursing home placement and have been associated with accelerated disease progression.” Researchers found that brexpiprazole treatment achieved a statistically significant reduction in agitation over a 12‐week treatment period, based on the Cohen‐Mansfield Agitation Inventory. The most common side effects with brexpiprazole among patients with agitation associated with dementia due to Alzheimer's disease include headache, dizziness, urinary tract infection, nasopharyngitis and sleep disturbances.
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