FDA Approves First Treatment for Alzheimer’s-Associated Agitation

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This story was updated on May 17, 2023, to reflect the FDA’s approval of Rexulti for treating Alzheimer’s agitation. 

On May 10, the FDA approved the use of atypical antipsychotic drug Rexulti (brexpiprazole) for treating agitation associated with Alzheimer’s dementia, making it the first FDA-approved treatment for agitation associated with Alzheimer’s in the U.S. 

Agitation is among the most challenging aspects of caring for someone with the disease and has a significant impact on quality of life for patients, family members, and caregivers. It is reported in approximately half of people with Alzheimer’s dementia and is associated with earlier nursing home placement, according to the drug’s manufacturer

In two Phase 3 randomized clinical trials, the drug was shown to reduce agitation symptoms by 31% compared to placebo.  

It was approved for a Supplemental New Drug Application following a priority FDA review for drugs that promise to offer a significant improvement on current therapies. 

An FDA advisory committee on April 14 recommended the use of Rexulti for treating agitation associated with Alzheimer’s dementia. The committee voted 9-1 to recommend a favorable benefit-risk profile for the drug’s proposed use.  

Rexulti was approved in 2015 for treatment of schizophrenia and as an add-on treatment for major depressive disorder in adults. The drug carries a warning for an increased mortality risk in elderly patients with dementia-related psychosis. 

Alzheimer’s disease is the most common cause of dementia, affecting an estimated 6.5 million people aged 65 and older in the U.S. Although cognitive decline is the predominant symptom, behavioral and psychiatric symptoms of dementia, including agitation, aggression, and irritability, are common, affecting approximately 40% of all Alzheimer’s patients.  

The FDA notes that behavioral and psychiatric symptoms are associated with a higher risk of accelerated disease progression, functional decline, decreased quality of life, greater caregiver burden, increased out of-home placement, and earlier death. Most patients experience initial onset of symptoms in later stages of Alzheimer’s and worsening symptoms as the disease progresses.  

Several non-medication behavior interventions have been studied for the treatment of Alzheimer’s-related agitation; some of the most effective techniques are distraction, redirection, massage, music therapy, physical activity, aromatherapy, and simulated presence therapy.  

Source: U.S. Food & Drug Administration  

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