Otsuka, Lundbeck get FDA OK for new indication for Rexulti

The Food and Drug Administration has given Otsuka and Lundbeck approval for Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer's disease. This is the first FDA-approved treatment option for this indication.

"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, director of the division of psychiatry in the FDA's Center for Drug Evaluation and Research. "These symptoms are leading causes of assisted living or nursing home placement and have been associated with accelerated disease progression."

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Dementia is a serious and debilitating neurological condition characterized by a progressive decline in one or more cognitive domains in the brain. Dementia can seriously impair an individual's ability to function independently. As a result, many people living with dementia require permanent at-home or residential care. Alzheimer's disease is the most common cause of dementia. 

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Alzheimer's is an irreversible, progressive brain disorder affecting more than 6.5 million Americans. Patients with dementia often have behavioral and psychological disturbances. Agitation is among the most persistent, complex, stressful and costly aspects of care among patients with behavioral and psychological symptoms of dementia.