The FDA just approved Rexulti (brexpiprazole) for the treatment of agitation associated with dementia due to Alzheimer’s disease.
The FDA approved the drug based on new data from two separate three month studies in which patients showered “statistically significant and clinically meaningful improvements” on the commonly used Cohen-Mansfield Agitation Inventory scale. This is a widely accepted way to understand the frequency and intensity of dementia-related agitation.
This drug was considered by the FDA to have an acceptable safety profile based on the new research, especially given the fact that the symptoms are the leading causes of assisted living and nursing home placement and have been known to be associated with accelerated disease progression, according to the FDA’s center of drug evaluation and research, psychiatry.
There are some caveats of which people should be aware. For example, the study researchers state that common side effects include headache, dizziness, urinary tract infection, nasopharyngitis, and sleep disturbances (both somnolence and insomnia).
In addition, 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.