May 12, 2023–Brexpiprazole has now been approved by the FDA for the treatment of agitation in Alzheimer’s dementia. Agitated behaviors are common in those with moderate or advanced Alzheimer’s dementia and these symptoms contribute substantially to caregiver burden, institutionalization, and faster cognitive decline. Yesterday’s decision marks the first approval in the United States of a medication for these symptoms. The approval was based on the results of three 12-week treatment studies. The studies collectively showed modest reduction in the frequency of specific agitated behaviors and lower severity on a clinician-rated measure. In one of the studies, 56% of those treated…
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