May 11 (UPI) -- The Food and Drug Administration on Thursday announced the supplemental approval of Alzheimer's disease drug Rexulti, which treats agitation.
Rexulti is an oral tablet that treats agitation associated with dementia caused by Alzheimer's. Dementia is a debilitating neurological condition characterized by a progressive decline in one or more cognitive domains in the brain. It can impair one's ability to function independently.
Rexulti is co-developed by Otsuka Pharmaceutical Co. Ltd. and Lundbeck LLC. The approval makes Rexulti the first pharmacological treatment approved in the United States for agitation associated with dementia caused by Alzheimer's disease.
"Agitation is one of the most common and challenging aspects of care among patients with dementia due to Alzheimer's disease," Tiffany Farchione, director of the Division of Psychiatry in the FDA's Center for Drug Evaluation and Research, said in a statement.
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Farchione described agitation's symptoms as include pacing, restlessness, and verbal and physical aggression.
"These symptoms are leading causes of assisted living or nursing home placement and have been associated with accelerated disease progression," she said.
In two studies, patients who received two milligrams or three milligrams of Rexulti showed statistically significant and clinically meaningful improvement in total Cohen-Mansfield Agitation Inventory scores at week 12 compared to those taking a placebo.
"Patients with dementia often have behavioral and psychological disturbances," the FDA said. "Agitation is among the most persistent, complex, stressful, and costly aspects of care among patients with behavioral and psychological symptoms of dementia."
Makoto Inoue, president and representative director of Otsuka, said the drug will make a difference for families and caregivers of dementia patients dealing with the complexities of agitation associated with the disease.
"This approval is a testament to our commitment and unwavering support of patients and caregivers to lessen the symptoms of agitation associated with dementia due to Alzheimer's disease," Deborah Dunsire, CEO and president, Lundbeck, said in a statement.
"We look forward to offering this first FDA-approved treatment option to address this significant unmet need for patients," Dunsire said. "We are grateful to the patients and caregivers who participated in these important trials."
