The U.S. Food and Drug Administration (FDA) has approved the first drug to treat agitation in people with Alzheimer’s disease, concluding that the potential benefits of symptom relief for dementia patients outweigh the mortality risks.
Brexpiprazole (Rexulti), has been available in the United States since 2015 as a treatment for major depressive disorder and schizophrenia. The drug belongs to a family of medicines known as atypical antipsychotics that carry a black box warning, the FDA’s strongest, about the significantly increased mortality risk for elderly people with dementia.
Agitation Is a Common Symptom Among Older Adults Living With Alzheimer’s Disease
The approval follows the recommendation of an FDA advisory panel, which earlier this month voted 9 to 1 to approve Rexulti for agitation in people with Alzheimer’s disease. The panel of independent medical experts determined that Rexulti’s ability to ease agitation in these patients outweighed an up to 70 percent increased risk of premature death among elderly individuals who took the drug.
Alzheimer’s disease is the most common form of dementia among older adults, according to the U.S. Centers for Disease Control and Prevention (CDC). An estimated 6.5 million Americans are currently living with the condition, and it’s the fifth leading cause of death among people 65 and older.
Agitation is common in these patients, affecting up to half of patients with Alzheimer’s disease overall and the vast majority of those living in nursing homes, according to a 2021 study. People with this behavioral condition tend to have frequent bouts of restlessness, agitation, aggressiveness, and emotional distress that can increase their risk of harming themselves or their caregivers.
Rexulti Significantly Reduced Agitation in 2 Out of 3 Clinical Trials
The FDA reviewed results from three late-stage clinical trials for Rexulti. Two of these studies found that the drug significantly reduced agitation in Alzheimer’s disease patients after 12 weeks of treatment. In the third study, however, researchers didn’t find a statistically meaningful difference in agitation after 12 weeks between Rexulti and a placebo.
In these three studies, eight patients (1.2 percent) on Rexulti died, compared with one patient (0.26 percent) on placebo.
Mortality risks have long been an issue with antipsychotics. The FDA issued a public health advisory in 2005 warning that antipsychotics carried an increased risk of premature death when used to treat behavioral disorders in elderly people with dementia.
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