Thursday, May 11, 2023

FDA Approves Rexulti for Agitation Associated With Dementia Due to Alzheimer’s Disease

The U.S. Food and Drug Administration (FDA) yesterday approved the expanded use of Rexulti (brexpiprazole) for the treatment of agitation associated with dementia due to Alzheimer’s disease (AD).

“Agitation associated with dementia due to Alzheimer’s disease is a common neuropsychiatric symptom that is reported in approximately half of all patients with Alzheimer’s dementia,” wrote Otsuka Pharmaceutical Co. Ltd. and Lundbeck LLC, makers of the medication, in a press release. The symptoms cover “a large group of behaviors occurring in patients with Alzheimer’s disease, such as pacing, gesturing, profanity, shouting, shoving, and hitting.”

Brexpiprazole was first approved by the FDA in 2015, as an adjunctive therapy to antidepressants in adults with major depressive disorder and as a treatment for adults with schizophrenia. In 2021, the FDA expanded the use of the medication for the treatment of adolescents over the age of 13 with schizophrenia. Earlier this year, Otsuka and Lundbeck announced that the FDA would review the companies’ supplemental New Drug Application for brexpiprazole for the treatment of agitation associated with AD.

In a hearing last month, the FDA’s Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee voted 9-1 in favor of the approval of brexpiprazole for the new indication, noting the data presented by Otsuka and Lundbeck suggested that the benefits of the medication outweighed the risks for patients with these symptoms.

A briefing document released prior to the April meeting describes some of these data, including several phase 3, 12-week, randomized, placebo-controlled studies. “Results from Studies 331-12-283 and 331-14-213 suggest that brexpiprazole exhibited a statistically significant treatment effect in the reduction of agitation over a 12-week treatment period, while also showing a similar safety profile relative to its use in adults with schizophrenia and major depressive disorder,” the document stated. “[B]rexpiprazole’s effect on mortality appears to be consistent with the known risk with other antipsychotics in elderly patients with dementia.”

According to the updated medication label, Rexulti is to be taken daily. The medication is not approved for the treatment of Alzheimer’s patients with dementia-related psychosis without agitation.

For related news, see the Psychiatric News article “Experts Discuss Challenges of Treating Neuropsychiatric Symptoms of Dementia.” 


The content of Psychiatric News does not necessarily reflect the views of APA or the editors. Unless so stated, neither Psychiatric News nor APA guarantees, warrants, or endorses information or advertising in this newspaper. Clinical opinions are not peer reviewed and thus should be independently verified.