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

The U.S. Food and Drug Administration (FDA) yesterdayapproved 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 apress 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 Lundbeckannounced that the FDA would review the companies ’ supplemental New Drug Application for brexpiprazole for the treatment of agitation associated with AD.In ahearing last month, the FDA ’s Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committeevoted 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 t...
Source: Psychiatr News - Category: Psychiatry Tags: agitation Alzheimer ' s disease brexpiprazole dementia FDA Food and Drug Administration major depressive disorder Rexulti schizophrenia Source Type: research