Otsuka and Lundbeck announce that they have received FDA approval for REXULTI for the treatment of agitation associated with dementia due to Alzheimer’s disease.

United States: The U.S. Food and Drug Administration (FDA) on May 10, 2023, approved the long-awaited oral tablets for the treatment of agitation linked with dementia brought on by Alzheimer's disease. A devastating and crippling neurological disorder known as dementia is characterized by a steady decrease in one or more cerebral cognitive domains. The ability of a person to act independently can be severely compromised by dementia. Many dementia patients require ongoing in-home or residential care. About half of all patients with Alzheimer's dementia suffer from agitation, a typical neuropsychiatric symptom of dementia caused by the condition. The medical condition has a significant influence on the patients', their families', and the carers' quality of life. REXULTI is expected to address these issues. The application for approval of REXULTI was given Fast Track status by the FDA. Fast Track is a procedure created to make the development and review of medications to treat critical illnesses and fulfil an unmet medical need easier and faster. Earlier patient access to significant novel drugs is the objective.

Two 12-week, randomized, double-blind, placebo-controlled, fixed-dose studies were used to evaluate the effectiveness of REXULTI for the treatment of agitation associated with dementia caused by Alzheimer's disease. Patients for these studies had to have an elevated risk of Alzheimer's dementia, a score between 5 to 22 on the Mini-Mental State Examination (MMSE) demonstrating whether they had cognitive impairment, and the kind, frequency, and degree of agitation behaviors that required medication. The trial subjects' ages ranged from 51 to 90.

In 2015, brexpiprazole received approval in the United States for the treatment of adult schizophrenia and as an adjuvant therapy to antidepressants in adults with major depressive disorder (MDD). In 2017 and 2019, respectively, Health Canada approved brexpiprazole for the adjunctive treatment of MDD and schizophrenia. In 2018 the European Medicines Agency (EMA) and the Japanese Ministry of Health, Labour, and Welfare both permitted it for the treatment of schizophrenia.

In addition to headache, dizziness, urinary tract infection, nasopharyngitis, and sleep problems (both somnolence and insomnia), the most frequent side effects among individuals with agitation associated with dementia brought on by Alzheimer's disease include headache and dizziness. REXULTI is going to continue with the Boxed Warning that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

Makoto Inoue, President and Representative Director of Otsuka commented, “Today marks a major milestone for patients, caregivers, and families navigating the complexities of agitation associated with dementia due to Alzheimer’s disease. Otsuka Pharmaceutical will continue its efforts to engage and provide options for those impacted by this devastating condition.”

Deborah Dunsire, CEO and President, Lundbeck said, “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. We look forward to offering this first FDA-approved treatment option to address this significant unmet need for patients. We are grateful to the patients and caregivers who participated in these important trials.”